report on existing policies, risk management guidance …

REPORT ON EXISTING POLICIES, RISK

MANAGEMENT GUIDANCE AND

RECOMMENDATIONS FOR POLICY’S

Authors: Eduardo de Oliveira Fernandes; Gabriela Ventura Silva; Anabela Martins from IDMEC – Porto (WP8 leader) with collaboration of John Bartzis and Sani Dimitroulopoulou from UOWM and Paolo Carrer

and Marilena Trantallidi from UMIL

August 2013

EPHECT is co-funded by European Union (Executive Agency for Health and Consumers - EAHC)

framework of the Health Programmes 2006-2013

“© IDMEC, UMil, UOWM All rights on the materials described in this document rest with IDMEC, UMil and UOWM. This document is produced in the frame of the EPHECT-project. The EPHECT-project is co-funded by the European Union in the framework of the health Programmes 2006-2013. The information and views set out in this document are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf, nor the authors may be held responsible for the use which may be made of the information contained herein. Reproduction is authorized provided the source is acknowledged.”

Distribution List

I

DISTRIBUTION LIST

EPHECT associated partners

EPHECT collaborative partners

EVALUATOR The present report has been evaluated by Mr. Stylianos Kephalopoulos, Joint Research Centre (Ispra)

Distribution List

III

Summary

V

SUMMARY

The present report seeks to meet the objectives fixed under EPHECT Project in Work Package 8: Risk

management guidance and policy options.

The current policies related to indoor air emissions from the consumer products in EU MS are

reviewed, and some proposals on exposure reduction strategies, for consumers, manufacturers as

well as policy makers, are formulated. The expected health promotion outcomes of EPHECT, i.e.

recommendations for policy makers and risk management for users, are formulated in order to

achieve intermediate health outcomes in time, when guidelines and recommendations will be

implemented by European citizens. This healthy lifestyle will then induce a reduction of the user's

exposure to consumer product emissions, and thus it will lead to an improvement of the quality of

life.

In what regards the review, presented in Part I of the report, they are presented the measures

currently in place in the EU related to consumer products and, more specifically, to those which put

limits on chemical emissions or on the contents of some chemical contaminants in the product

composition. To note that not all consumer products are within the scope of EPHECT project. Only

the consumer products known as potential sources of hazardous and other health relevant air

pollutants in dwellings, e.g., products that emit pollutants to the indoor air and which major

exposure route is by inhalation.

The primary focus of the review is on European Union level policies (directives, codes, regulations

and international agreements) with impact on the utilization of some substances as ingredients of

consumer products either by the prohibition of using certain substances, or by imposing restrictions

on the used amounts: EU policies on chemicals (REACH), consumer products (GPSD), dangerous

substances (CLP/GHS) and use of biocides (BPD). More specific regulations on consumer products are

also assessed: cosmetics, detergents and toys. It can be observed that the limits imposed are

specified in terms of the content and never in terms of emission, which can be explained by the

absence of specific standards. There is also an important lack on toxicological data. There is a wide

quantity of ingredients that were not yet evaluated in terms of toxicology, and are in consequence

not covered by the regulations. The new Consumer Product Safety Regulation and Market

Surveillance Regulation launched in February 2013 and currently under discussion seem to be

promising and some progress is expected.

Table of Contents

VI

Voluntary European Actions as the European EcoLabel and Green Public Procurement (GPP) are also

referred in the review. A particular but important aspect to be highlighted is the fact that the

EcoLabel and GPP criteria concerning fragrances refer to IFRA (International Fragrance Association),

but it should be noted that IFRA limits were based only on risk assessments for dermal sensitization.

The exposure by inhalation was not considered.

An overview of what was and is actually been performed by the European Committee for

Standardization (CEN) in what concerns consumer products is included in the review. As CEN is a

major provider of European Standards and technical specifications, it is important to obtain this

information in order to identify possible fields of intervention as, in fact, the number of Technical

Committees dedicated to consumer products within EPHECT scope is very small. CEN appears as a

window of opportunity for the creation of Working Groups dedicated to emissions measurements of

consumer products.

The review focuses also on national policies on consumer products in European Member States

which are not simply the transposition of European Directives or Regulations to the national laws.

This chapter is without doubt the least accomplished, caused by difficulties in obtaining information.

Finally, the review focuses on voluntary actions such as industry standards, product labelling

schemes and professional good practices applied to consumer products. It can be seen that the

industry is quite active in the field of the safety of products and in communicating this message to

the consumers. However, much more might be even required if a deeper knowledge of the risk

associated with the use of consumer products is obtained.

Part II of the report focuses in the risk management guidance in using consumer products, and some

possible recommendations to policy-makers and consumers. It will be best to remember the

strategies previously proposed to a better IAQ and widely accepted, that form the basis of the

recommendations. The EC project EnVIE (Oliveira Fernandes et al., 2008), sponsored by the DG

Research made a major contribution in this context proposing a framework to address and organize

the IAQ management issue from the Policy perspective. From EnVIE one could dress two main

principles or lines for action:

1. The first strategy to manage the IAQ is the ‘source control’ strategy, meaning that what is not

emitted or diluted indoors does not affect the IAQ status;

2. The second and, in fact, the ultimate strategy is ventilation as an ‘exposure control’ strategy

and not as a panacea for every IAQ problem;

Summary

VII

The first option is in the hands of the manufacturers and policy makers that can force to decrease the

contaminants present in the consumer products. Another way considered to control exposure was

the restriction of the time spent in a particular contaminated space and, as the ultimate solution, the

dilution with increased ventilation, which can be implemented by the consumer. Some

recommendations under this context are presented in Part II of the report.

To finish, in Annex are presented the results of a survey undertaken at the final stage of the final

event of the EPHECT project, that took place in 18th of September at the European Parliament in

Brussels , with the objective to present the outcomes of the project. The survey aimed to collect the

opinion of the audience, using an electronic voting system. There were six multiple choice questions

to which the responses were particularly relevant and supportive of the EPHECT objectives and

respective follow-up. The audience had a quite good representation of industry (34%) and the

majority recognized the importance of most of choices of potential policies (low emitting products,

guidelines for indoor air pollutants), reinforcing the importance of legislative labelling (40%),

supporting initiatives towards reducing primary emissions (source control) and labelling (55%).

Table of Contents

VIII

TABLE OF CONTENTS

Distribution List ____________________________________________________________________ I

Summary ________________________________________________________________________ V

Table of contents ________________________________________________________________ VIII

List of tables _____________________________________________________________________ XI

List of acronyms _________________________________________________________________ XII

PART 1 _________________________________________________________________________ XIII

Review of the policies related with chemical content or chemical emissions from consumer products _______________________________________________________________________ XIII

1. INTRODUCTION 1

2. EU POLICIES 3 2.1. Regulation (EC) 1907/2006 - Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) _____________________________________________________________3

2.2. General Product Safety Directive (GPSD), 2001/95/EC ____________________________5

2.2.1. RAPEX – Rapid Alert System for non-food dangerous products ________________ 6

2.2.2. Emergency measures ________________________________________________ 6

2.2.3. GPSD implementation in the European countries __________________________ 8

2.2.4. The new proposal of Consumer Product Safety Regulation and Market Surveillance

Regulation launched in February 2013 ___________________________________________ 8

2.3. CLP/GHS - Classification, labelling and packaging of substances and mixtures _________9

2.4. Biocidal Products Directive (BPD) 98/8/EC ___________________________________ 11

2.5. Toy Safety Directive (2009/48/EC) _________________________________________ 12

Summary

IX

2.6. Cosmetics Directive 76/768/EC ____________________________________________ 14

2.7. Regulation (EC) Nº 1223/2009 on Cosmetic Products __________________________ 15

2.8. EU Detergents Legislation ________________________________________________ 18

2.9. European EcoLabel _____________________________________________________ 20

2.9.1. All purpose cleaners ________________________________________________ 21

2.9.2. Hand Dishwashing Detergents ________________________________________ 22

2.9.3. Soaps and Shampoos ________________________________________________ 23

2.10. Green Public Procurement _______________________________________________ 24

2.11. CEN Standards _________________________________________________________ 25

2.12. EU-LCI HARMONIZATION _________________________________________________ 30

3. NATIONAL POLICIES IN EUROPE 32 3.1. France _______________________________________________________________ 32

3.2. Nordic countries _______________________________________________________ 34

3.3. Germany _____________________________________________________________ 38

Wooden Toys __________________________________________________________ 38

3.4. East Countries _________________________________________________________ 40

4. PROFESSIONAL AND INDUSTRY STANDARDS & PRACTICES 42 4.1. IFRA – International Fragrance Association __________________________________ 42

4.2. HERA ________________________________________________________________ 44

4.3. Air fresheners product Stewardship programme ______________________________ 45

4.4. Clean Right ____________________________________________________________ 47

4.5. Green Good Housekeeping Seal ___________________________________________ 47

5. FINAL REMARKS 51

PART 2 _________________________________________________________________________ 53

Recommendations _______________________________________________________________ 53

1. RISK MANAGEMENT GUIDANCE FOR CONSUMER PRODUCTS 55 1.1. The consumer _________________________________________________________ 55

1.2. The use of a consumer product ____________________________________________ 56

2. RECOMMENDATIONS FOR POLICY MAKERS 59

3. RECOMMENDATIONS FOR CONSUMERS 63

Annex _________________________________________________________________________ 65

Results on Survey undertaken at the Final Event at the European Parliament 65

References______________________________________________________________________ 69

Table of Contents

X

List of Tables

XI

LIST OF TABLES

Table 1. Example of the restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles established by REACH. Table 2. Generic concentration limits of ingredients of a mixture classified as carcinogen that trigger the classification of the mixture. Table 3. Generic concentration limits of ingredients of a mixture classified as germ cell mutagens that trigger the classification of the mixture. Table 4. Generic concentration limits of ingredients of a mixture classified as either skin sensitisers or respiratory sensitisers that trigger the classification of the mixture. Table 5. Allergenic substances allowed in toys but with restrictions (< 100mg/kg). Table 6. Allergenic substances that shall be listed if added to a toy at concentrations exceeding 100mg/kg. Table 7. Some of the substances prohibited in cosmetic products (part of Annex II of (EC) Nº 1223/2009). Table 8. Some of the substances allowed but subject to restrictions (part of Annex III of (EC) Nº 1223/2009).

Table 9. Some of the preservatives allowed but subject to restrictions (part of Annex V of (EC) Nº 1223/2009).

Table 10. Work programme of Consumer Products Technical Committees Table 11. Example of standards already prepared by CEN/TC 52 (Safety of toys) Table 12. Example of standards already prepared by other Technical Committees (TC 369, SS H99 and TC 276) Table 13. Example of standards already prepared by CEN/SS S26 Environmental management Table 14. Substances with restrictions under Nordic Ecolabel Requirements (R14) for cleaning products Table 15. Classification not allowed under Nordic Ecolabel requirements for cleaning products

Table 16. Limit values for Test Chamber Emission Measurements.

Table 17. Migration limit values.

List of Acronyms

XII

LIST OF ACRONYMS

AISE International Association for Soaps, Detergents and Maintenance Products

BPD Biocidal Products Directive

CEN European Committee for Standardization

CFC Chlorofluorocarbon

CLP Classification, labelling and packaging of substances and mixtures

CMR Carcinogenic, Mutagenic or toxic for Reproduction

CSA Chemical Safety Assessment

DMF Dimethylfumarate

ECHA European Chemical Agency

GHS Globally Harmonised System of Classification and Labelling of Chemicals

GPP Green Public Procurement

GPSD General Product Safety Directive

HERA Human and Environmental Risk Assessment

IFRA International Fragrance Association

INCI International Nomenclature of Cosmetic Ingredients

PBT Persistent, Bioaccumulative and Toxic

RAPEX Community Rapid Information System

REACH Registration, Evaluation, Authorisation and Restriction of Chemicals

SVHC Substance of Very High Concern

TC Technical Committee

vPvB Very Persistent and Very Bioaccumulative

Part 1

XIII

PART 1

Review of the policies related with

chemical content or chemical emissions

from consumer products

Chapter 1 Introduction

1

1. INTRODUCTION

This report assesses the policies that are related with consumer products and, more specifically,

those policies which limit chemical emissions or content of chemical contaminants in the product

composition. It should be noted that not all consumer products are within the scope of the EPHECT

project. Only the consumer products known to be potential sources of hazardous and other health

relevant air pollutants in dwellings, e.g. products that emit pollutants to air and the major exposure

route for occupants to these air pollutants is inhalation.

To enrichment of the report, contributions were asked to focal contacts in several countries in

Europe, but the answer’s rate was extremely low.

While reporting, the primary focus was on European level policies (directives, codes, regulations and

international agreements) with impact on the utilization of some substances as ingredients of

consumer products; either by the prohibition of using certain substances, either by imposing

restrictions on the amounts used.

An overview of what was and is actually being performed by the European Committee for

Standardization (CEN) in what concerns consumer products was also included.

Secondly, the report focuses on national policies in European countries on consumer products which

are not simply the transposition of European Directives or Regulations to the national laws.

Finally the report focuses on voluntary actions such as industry standards, product labelling schemes

and professional good practices applied to consumer products.

For each policy identified, the limits, when existent, on the compounds classified as priority in the

frame of the EPHECT project are presented in the text.

Chapter 2 EU Policies

3

2. EU POLICIES

In the context of this review eleven EU-policies related with the emissions and content of chemical

substances in consumer products have been identified and are presented in detail.

2.1. Regulation (EC) 1907/2006 - Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

The purpose of the REACH regulation is to protect human health and environment. It states that it is

the manufacturers’, importers’ and downstream users’ responsibility to ensure that substances in

use do not adversely affect human health or environment. It follows the precautionary principle.

REACH is concerned with all chemical substances; not only those used in industrial processes but also

those used in our day-by-day lives, for example, in cleaning products or paints as well as in products

such as clothes, furniture and electrical appliances. Therefore, this regulation has an impact on most

companies across the EU.

For each substance manufactured or imported in quantities of ≥1 tonne/year, there is a general

obligation for manufacturers and importers to submit a registration to the European Chemical

Agency (ECHA). This also applies to substances manufactured or imported as part of a preparation.

A chemical safety assessment (CSA) is required for all substances that are manufactured or imported

for an amount ≥10 tonnes/year. This is done to assess the risks related to the manufacturing and use

of a substance. If a substance is classified as dangerous, PBT (Persistent, Bioaccumulative and Toxic)

or vPvB (Very Persistent and Very Bioaccumulative), the CSA shall also include an exposure

assessment and a risk characterization. If necessary, substances can be banned from the market.

The procedure of authorisation aims to assure that the risks from ‘Substances of Very High Concern’

(SVHC) are properly controlled and that those substances are progressively replaced by suitable

alternatives while ensuring the good functioning of the EU internal market. Substances of very high

concern include:

- carcinogenic, mutagenic or toxic to reproduction,

- persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative

(vPvB),

- other substances identified by scientific evidence as causing probable serious effects to

human health or environment.

‘Restrictions’ is a type of measure to allow for the protection of the human health and the

environment from unacceptable risks posed by chemicals. Restrictions may limit or ban the


4

manufacture on the market or the use of a substance. A restriction applies to any substance on its

own, in a mixture or in an article, including those that do not require registration. It can also apply to

imports. A Member State or the ECHA can, on request of the European Commission, propose

restrictions if it is found that the risks require to be addressed on an EC wide basis.

REACH adopts a substance based approach so that the obligations do not directly apply to the

preparations and goods or articles. Suppliers of those final products shall inform their customers

about SVHC in concentrations above 0.1% by weight.

Some of the restrictions were incorporated into the REACH Regulation, which has been amended in

2009 for some specific substances through the regulation 552/2009 in Annex XVII. An example for

benzene, toluene and some phthalates restrictions under REACH is presented in table 1.

Table 1. Example of the restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles established by REACH.

Column 1 Designation of the substance, of the group

of substances or of the mixture

Column 2 Conditions of restriction

5. Benzene CAS No 71-43-2 EC No 200-753-7

1. Shall not be used in toys or parts of toys where the concentration of benzene in the free state is greater than 5 mg/kg (0.0005%) of the weight of the toy or part of the toy. 2. Toys and parts of toys not complying with paragraph 1 shall not be placed on the market. 3. Shall not be placed on the market, or used, — as a substance, — as a constituent of other substances, or in mixtures in concentrations equal to, or greater than 0.1 % by weight. 4. However, paragraph 3 shall not apply to: (a) motor fuels which are covered by Directive 98/70/EC; (b) substances and mixtures for use in industrial processes not allowing for the emission of benzene in quantities in excess of those laid down in existing legislation.

48. Toluene CAS No 108-88-3 EC No 203-625-9

Shall not be placed on the market,or used as a substance or in mixtures in a concentration equal to or greater than 0.1 % by weight where the substance or mixture is used in adhesives or spray paints intended for supply to the general public.

51. The following phthalates (or other CAS and EC numbers covering the substance): (a) Bis (2-ethylhexyl) phthalate (DEHP) CAS No 117-81-7 EC No 204-211-0 (b) Dibutyl phthalate (DBP) CAS No 84-74-2 EC No 201-557-4 (c) Benzyl butyl phthalate (BBP) CAS No 85-68-7 EC No 201-622-7

1. Shall not be used as substances or in mixtures, in concentrations greater than 0.1 % by weight of the plasticised material, in toys and childcare articles. 2. Toys and childcare articles containing these phthalates in a concentration greater than 0.1 % by weight of the plasticised material shall not be placed on the market. 3. The Commission shall re-evaluate,the measures provided for in relation to this entry in the light of new scientific information on such substances and their substitutes, and if justified, these measures shall be modified accordingly. 4. For the purpose of this entry “childcare article” shall mean any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children.


5

2.2. General Product Safety Directive (GPSD), 2001/95/EC

The GPSD (1) is intended to ensure a high level of product safety throughout the EU for consumer

products that are not covered by any specific sector legislation (e.g. toys, chemicals, cosmetics,

machinery). This Directive also complements the provisions of the sector legislation which does not

cover certain matters, for instance, in relation to producers’ obligations and the authorities’ powers

and tasks.

The Directive provides a generic definition of a safe product (Chapter I, Article 2):

‘safe product’ shall mean any product which, under normal or reasonably foreseeable

conditions of use including duration and, where applicable, putting into service, installation

and maintenance requirements, does not present any risk or only the minimum risks

compatible with the product's use, considered to be acceptable and consistent with a high

level of protection for the safety and health of persons, taking into account the following

points in particular:

o the characteristics of the product, including its composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;

o the effect on other products, where it is reasonably foreseeable that it will be used with other products;

o the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product;

o the categories of consumers at risk when using the product, in particular children and

the elderly.

Products must comply with this definition. It is also stated that ‘Producers shall be obliged to place

only safe products on the market’ (Chapter II, Article 3).

If there are no specific national rules, the safety of a product is assessed in accordance with:

- European standards,

- Community technical specifications,

- Good practice codes,

- The state of the art and the expectations of the consumers.

The GPS directive covers only risks to human health and safety. Risks to environment, plants and

animals are not included.

In addition to the basic requirement to place only safe products on the market, producers should

give the consumer all the information needed to evaluate the risks associated with the product and

its use. Warning signs do not free the producer from their responsibility for product safety. The

producer should follow up the safety of the product after it is released to the consumer market

(post-market surveillance). For this purpose the Community Rapid Information System (RAPEX) was

created.


6

2.2.1. RAPEX – Rapid Alert System for non-food dangerous products

“RAPEX (2) is the EU rapid alert system to facilitate the rapid exchange of information between

Member States and the Commission on measures taken to prevent or restrict the marketing or use of

products posing a serious risk to the health and safety of consumers – with the exception of food,

pharmaceutical and medical devices, which are covered by other mechanisms. Since 1 January 2010,

as regards goods subject to EU harmonisation regulation, the system also facilitates the rapid

exchange of information on products posing a serious risk to the health and safety of professional

users and on those posing a serious risk to other public interests protected via the relevant EU

legislation (e.g. environment and security). Both measures ordered by national authorities and

measures taken voluntarily by producers and distributors are reported by RAPEX.”

Every Friday the Commission publishes a weekly overview of the products posing a serious risk as

reported by the national authorities (the RAPEX notifications). This weekly overview gives all

information on the product, its possible danger and the measures that were taken by the reporting

country.

“How does RAPEX work?

When a product (e.g. a toy, a childcare article or a household appliance) is found to be

dangerous the competent national authority takes appropriate action to eliminate the risk. It

can withdraw the product from the market; recall it from consumers or issue warnings. Then

the National Contact Point informs the European Commission (Directorate-General for Health

and Consumer) about the product, the risks it poses and the measures taken by the authority

to prevent risks and accidents.

The European Commission disseminates the information received to the National Contact

Points of all other EU countries. Weekly overviews of products posing a serious risk and the

measures taken to eliminate those risks are published on the internet.

The National Contact Points in each EU country ensure that the authorities responsible check

whether the newly notified product is present on the market. If so, the authorities take

measures to eliminate the risk, either by requiring that the product will be withdrawn from

the market, by recalling it from consumers or by issuing warnings.”

2.2.2. Emergency measures

“Under certain conditions, the EC may adopt a formal Decision requiring the Member States to ban

the marketing of an unsafe product, to recall it from consumers or to withdraw it from the market.

Such Decisions at Community level can be taken where:

Member States have different approaches to dealing with the risks posed by such dangerous

products;

urgency is required due to the risk posed by the product, and where no other Community laws

deal with that risk;

Such Decisions are the most effective way of eliminating the risk.


7

A Decision of this kind is only valid for a maximum of one year. To date, four such Decisions have been

taken at Community level:

a Decision on phthalates (substances which are used as softeners in plastics)

A Decision which temporarily banned the use of six phthalates in toys and childcare articles

was taken in 1999. Due to its temporary status, the Decision had to be regularly renewed. In

the meantime, Member States have also implemented national measures banning the use of

phthalates in toys. A series of risk assessments confirmed the safety concerns, and the need

for a permanent ban became evident. In July 2005, a permanent Directive banned the use of

phthalates in toys.

a Decision on lighters

On 11 May 2006, the Commission adopted Decision 2006/502/EC requiring Member States to

ensure that, as of 11 March 2008: Cigarette lighters placed on the EU market must be child

resistant; novelty lighters can no longer be placed on the market; all lighters must be safe. EU

bans sale of non-child resistant and novelty cigarette lighters.

a Decision on magnetic toys

On 21 April 2008, the Commission adopted Decision 2008/329/EC requiring Member States to

ensure that, as of 21 July 2008, magnetic toys placed on the EU market must carry warning

labels. This applies to all toys that contain or consist of loose or detachable magnets, or

magnetic components of such size and shape that they can be swallowed by children. The

warning label must be carried on the packaging or be otherwise attached to the toy,

explaining the risks that it poses to children. The warning is a temporary solution to bridge

the gap until the CEN (European Standardisation Committee) produces the revised safety

standard for magnetic toys.

a Decision on dimethylfumarate (DMF)

On 17 March 2009, the Commission adopted Decision 2009/251/EC requiring Member States

to ensure that, as of 1 May 2009, all consumer products containing DMF are banned

(maximum limit: 0.1 mg DMF per kg of product or part of the product). DMF is a powerful

anti-mould chemical that has been applied to consumer products, such sofas and shoes, by

placing it into "desiccant" sachets accompanying the products. DMF evaporates from the

sachets into/onto the products, and from there penetrates through consumers’ clothes onto

their skin. DMF can provoke allergic reactions causing skin itching, irritation, redness, burns

and rheumatic pain. The dermatitis can be particularly difficult to heal in severe cases, and

may require oral corticosteroids (instead of the usual topical steroids).”


8

2.2.3. GPSD implementation in the European countries

A Report was prepared by DG Sanco (3) in order to compare the approach used by the countries from

European Union and European Economic Area in the implementation of GPSD. In this report the

relevant regulatory and conformity assessment bodies for each country, are identified. The Report

provides a detailed overview of the approach to identifying hazardous products and the risk

assessment methods adopted by each country in determining the appropriate regulatory action to be

taken.

2.2.4. The new proposal of Consumer Product Safety Regulation and Market Surveillance Regulation launched in February 2013

The European Commission proposed in February 2013 new rules to improve the safety of consumer products circulating in the Single Market and to step-up market surveillance concerning all non-food products, including those imported from 3rd countries. This proposal for a Regulation on consumer product safety, which will replace Directive 2001/95/EC of the European Parliament and of the Council on general product safety1 (the "General Product Safety Directive" or simply GPSD), concerns manufactured non-food consumer products. According EC, “this will contribute both to strengthening consumer protection and to creating a level playing field for businesses. Unsafe products should not reach consumers or other users and their improved identification and traceability will be a key improvement that will help to take them quickly out of the market”. The two legislative proposals are complemented by a multi-annual plan for market surveillance setting out 20 concrete actions to be undertaken from now to 2015 to improve market surveillance under the current regulatory framework and until the new rules come into effect.

Improved product safety and market surveillance

At the moment, Union rules on market surveillance and consumer product safety are fragmented and scattered over several different pieces of legislation, thus creating gaps and overlaps. The legislative proposals that the Commission proposed will enable better coherence of the rules regulating consumer products identification and traceability and improved coordination of the way authorities check products and enforce product safety rules across the European Union.

The key changes of package are:

Alignment of the general obligations of economic operators to ensure the safety of all consumer products with clearer responsibilities for manufacturers, importers and distributors.

More effective tools to enforce safety and other product-related requirements and to take action against dangerous and non-compliant product across all sectors through a single set of coherent rules for market surveillance.

Improved traceability of consumer products throughout the supply chain – enabling a swift and effective response to safety problems (e.g. recalls). To do that manufacturers and importers shall ensure that products bear an indication of the country of origin of the product or, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product. For products manufactured in the Union, the indication shall refer to the Union or to a particular Member State. The indication of origin supplements the basic traceability requirements concerning


9

the name and address of the manufacturer. Such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the framework of bilateral or multilateral cooperation on consumer product safety for appropriate follow up actions

Creation of a more cooperative system of market surveillance across the EU.

Streamlined procedures for the notification of dangerous products, and synergies between the existing Rapid Alert Information System (RAPEX) and the Information and Communication System for Market Surveillance (ICSMS).

However, some aspects remain generalists, as the existence of the European Standards to assure the

safety requirements of the products. In Article 16 is written:

“The Commission may request one or several European standardisation organisations to draft or identify a European standard, which aims at ensuring that products that conform to such standard or parts thereof comply with the general safety requirement laid down in Article 4.” The Article 4 said: “Economic operators shall place or make available on the Union market only safe products”. Concluding, there is a high confidence in the manufacturer, as the assessment is based in industry self-declaration. The regulation does not foresee obligatory EC-type examination, by an independent third-party testing. There is of course the package on Market Surveillance that should verify if the product is respecting the safety requirements. Each Member State should implement market surveillance activities which shall be reported to the Commission every year. However the frequency of these surveillance acts is not defined and EC leave too much flexibility to individual Member States to decide on this matter. Equality with regards to the safety of consumer products in all European Member States may be compromised. By other side the proposal foresees the creation of European Reference Laboratories to contribute to effective market surveillance, what is an advantage of the new regulation. Although some points require more detailed and well defined actions, the new regulation gives more emphasis to the safety control, and the consumer could be more protected, if all the parties involved collaborate positively.

2.3. CLP/GHS - Classification, labelling and packaging of substances and mixtures

CLP (4) is the Regulation (EC) Nº 1272/2008, on classification, labelling and packaging of substances

and mixtures. This Regulation aligns previous EU legislation on classification, labelling and packaging

of chemicals to the GHS (Globally Harmonised System of Classification and Labelling of Chemicals). Its

main objectives are to facilitate international trade in chemicals and to maintain the existing level of

protection of human health and environment. The GHS is a United Nations system to identify

hazardous chemicals and to inform users about these hazards through standard symbols and phrases

on the packaging labels and through safety data sheets (SDS).

http://ec.europa.eu/consumers/safety/rapex/index_en.htm


10

The CLP Regulation was published in the Official Journal 31 December 2008 and entered into force on

20 January 2009. According to the Regulation, the deadline for substance classification according to

the new rules is 1 December 2010. For mixtures, the deadline will be 1 June 2015. After this

transitional period the CLP Regulation will ultimately replace the current rules on classification,

labelling and packaging of substances (Directive 67/548/EEC - Dangerous Substances Directive, under

the responsibility of DG Environment) and preparations (Directive 1999/45/EC - Dangerous

Preparations Directive, under the responsibility of DG Enterprise & Industry).

The classification of a substance is based on the relevant information available on its hazardous

properties. This information can include experimental data generated in tests for physical hazards,

toxicological and ecotoxicological tests, historical human data such as accident records or

epidemiological studies, or information generated in in vitro tests, (Quantitative) Structure Activity

Relationships ((Q)SAR), “read across”, or category approaches.

CLP does not require new testing for the purpose of classification for health or environmental

hazards. Testing for physical hazards is required unless adequate and reliable information is already

available. Although data may be provided through the application of REACH, it should be recognised

that the data set required by REACH (particularly at lower tonnages) will not necessarily enable the

comparison with the criteria for all hazard classes. Information may also be available from other EU

legislation for which there are specific requirements for test data to be generated such as Directive

91/414/EEC (Plant Protection Products) and Directive 98/8/EC (Biocidal Products), or from various

non-Community programmes.

A mixture of substances will be classified as carcinogen when, at least, one ingredient has been

classified as a Category 1A, Category 1B or Category 2 and it is present at or above the appropriate

generic concentration limit as shown in Table 2 for categories 1A, 1B and 2 respectively.

Table 2. Generic concentration limits of ingredients of a mixture classified as carcinogen that trigger the classification of the mixture.

Ingredient classified as: Generic concentration limits triggering classification of a mixture as:

Category 1A carcinogen Category 1B carcinogen Category 2 carcinogen

Category 1A carcinogen ≥ 0.1%

Category 1B carcinogen ≥ 0.1%

Category 2 carcinogen ≥ 1.0% [Note 1]

Note: The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units)

Note 1: If a category 2 carcinogen is present in the mixture as an ingredient at a concentration ≥ 0.1% a SDS shall be

available for the mixture upon request.

A mixture shall be classified as a mutagen when at least one ingredient has been classified as a

Category 1A, Category 1B or Category 2 mutagen and is present at or above the appropriate generic

concentration limit as shown in Table 3 for Category 1A, Category 1B and Category 2 respectively.

Table 3. Generic concentration limits of ingredients of a mixture classified as germ cell mutagens that trigger the classification of the mixture.

Ingredient classified as: Generic concentration limits triggering classification of a mixture as:

Category 1A mutagen Category 1B mutagen Category 2 mutagen


11

Category 1A mutagen ≥ 0.1%

Category 1B mutagen ≥ 0.1%

Category 2 mutagen ≥ 1.0%

Note: The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units)

A mixture shall be classified as a respiratory or skin sensitizer when at least one ingredient has been

classified as a respiratory or skin sensitizer and is present at or above the appropriate generic

concentration limit as shown in Table 4 for solid/liquid and gas respectively.

Table 4. Generic concentration limits of ingredients of a mixture classified as either skin sensitisers or respiratory sensitisers that trigger the classification of the mixture.

Ingredient classified as: Concentration triggering classification of a mixture as:

Skin sensitiser Respiratory sensitiser

Skin sensitiser All physical states Solid/Liquid Gas

≥ 0.1% [Note 1] - -

≥ 1.0% [Note 2] - -

Respiratory sensitiser - ≥ 0.1% [Note 1] ≥ 0.1% [Note 1]

- ≥ 1.0% [Note 3] ≥ 0.2% [Note 3]

Note 1: This concentration limit is generally used for the application of the special labelling requirements of Annex II section

2.8 to protect already sensitised individuals. A SDS is required for the mixture containing an ingredient above this

concentration.

Note 2: This concentration limit is used to trigger the classification of a mixture as a skin sensitiser.

Note 3: This concentration limit is used to trigger the classification of a mixture as a respiratory sensitiser.

2.4. Biocidal Products Directive (BPD) 98/8/EC

Biocidal products are necessary for the control of organisms that are harmful to human or animal

health and for the control of organisms that cause damage to natural or manufactured products;

however biocidal products can pose risks to humans, animals and the environment in a variety of

ways due to their intrinsic properties and associated use patterns.

This Directive, 98/8/EC (5), concerns the authorisation and the placing on the market for use of

biocidal products within the Member States; the mutual recognition of authorisations within the

Community; and the establishment at Community level of a positive list of active substances which

may be used in biocidal products.

The Directive requires a highly detailed evaluation of each biocide. More recently the European

Commission published a proposal for a Regulation on Biocidal Products. If adopted, the proposed

Regulation will repeal and replace the current Directive 98/8/EC and is foreseen to come into effect

as of 1 January 2013.

An active substance cannot be used as a biocide if it is classified according to Directive 67/548/EEC as

carcinogenic, mutagenic, toxic for reproduction, sensitising or is bioaccumulative and does not

readily degrade.

A low-risk biocidal product is a biocidal product which contains as active substance(s) only one or

more of those listed in Annex I A of the directive and which does not contain any substance(s) of


12

concern. Under the conditions of use, the biocidal product shall pose only a low risk to humans,

animals and the environment. From the list, one compound judge priority by EPHECT is present:

acrolein.

An exhaustive list of 23 product types are classified in Annex V of the Directive:

MAIN GROUP 1: Disinfectants and general biocidal products

Product-type 1: Human hygiene biocidal products

Product-type 2: Private area and public health area disinfectants and other biocidal products

Product-type 3: Veterinary hygiene biocidal products

Product-type 4: Food and feed area disinfectants

Product-type 5: Drinking water disinfectants

MAIN GROUP 2: Preservatives

Product-type 6: In-can preservatives

Product-type 7: Film preservatives

Product-type 8: Wood preservatives

Product-type 9: Fibre, leather, rubber and polymerised materials preservatives

Product-type 10: Masonry preservatives

Product-type 11: Preservatives for liquid-cooling and processing systems

Product-type 12: Slimicides

Product-type 13: Metalworking-fluid preservatives

MAIN GROUP 3: Pest control

Product-type 14: Rodenticides

Product-type 15: Avicides

Product-type 16: Molluscicides

Product-type 17: Piscicides

Product-type 18: Insecticides, acaricides and products to control other arthropods

Product-type 19: Repellents and attractants

MAIN GROUP 4: Other biocidal products

Product-type 20: Preservatives for food or feedstocks

Product-type 21: Antifouling products

Product-type 22: Embalming and taxidermist fluids

Product-type 23: Control of other vertebrates

2.5. Toy Safety Directive (2009/48/EC)

On 30 June 2009 the new Toy Safety Directive was published. It, substantially

Amends the old Directive across virtually all safety aspects.

Fulfils to the highest level the newest health and safety standards.

Improves the existing rules for the marketing of toys that are produced in and imported into

the EU in view to reducing toy related accidents and achieving long-term health benefits.


13

Directive 2009/48/EC applies to toys defined as "products designed or intended, whether or not

exclusively, for use in play by children under 14 years of age". It foresees 19 products not to be

considered as toys within the meaning of the Directive and 5 toys that the Directive is not applying to

(for example, toy steam engines, slings…etc.).

Chemicals that are susceptible to provoke cancer, change genetic information or harm reproduction,

so-called CMR (Carcinogenic, Mutagenic or toxic for Reproduction) substances, of category 1A, 1B or

2 under Regulation (EC) No 1272/2008, are no longer allowed in accessible parts of toys.

For certain substances like nickel tolerable limit values have been introduced and certain heavy

metals which are particularly toxic, like lead, may no longer be intentionally used in those parts of

toys that are accessible to children.

Allergenic fragrances are either completely forbidden, if they have a strong allergenic potential, or

have to be labelled on the toy if they are potentially allergenic for some consumers.

However, some allergenic fragrances shall be allowed provided that such presence is technically

unavoidable under good manufacturing practice and does not exceed 100 mg/kg. Those allergenic

fragrances are listed in Table 5.

Table 5. Allergenic substances allowed in toys but with restrictions (< 100mg/kg).

Name of the allergenic fragrance CAS Nº Name of the allergenic fragrance CAS Nº

Alanroot oil (Inula helenium) 97676-35-2 6-Methylcoumarin 92-48-8

Allylisothiocyanate 57-06-7 7-Methylcoumarin 2445-83-2

Benzyl cyanide 140-29-4 5-Methyl-2,3-hexanedione 13706-86-0

4 tert-Butylphenol 98-54-4 Costus root oil (Saussurea lappa

Clarke)

8023-88-9

Chenopodium oil 8006-99-3 7-Ethoxy-4-methylcoumarin 87-05-8

Cyclamen alcohol 4756-19-8 Hexahydrocoumarin 700-82-3

Diethyl maleate 141-05-9 Peru balsam, crude (Exudation of

Myroxylon pereirae (Royle) Klotzsch)

8007-00-9

Dihydrocoumarin 119-84-6 2-Pentylidene-cyclohexanone 25677-40-1

2,4-Dihydroxy-3-

methylbenzaldehyde

6248-20-0 3,6,10-Trimethyl-3,5,9-undecatrien-

2-one

1117-41-5

3,7-Dimethyl-2-octen-1-ol (6,7-

Dihydrogeraniol)

40607-48-5 Verbena oil (Lippia citriodora Kunth) 8024-12-2

4,6-Dimethyl-8-tert-butylcoumarin 17874-34-9 Musk ambrette (4-tert-Butyl-3-

methoxy-2,6-dinitrotoluene)

83-66-9

Dimethyl citraconate 617-54-9 4-Phenyl-3-buten-2-one 122-57-6

7,11-Dimethyl-4,6,10-dodecatrien-3-

one

26651-96-7 Amyl cinnamal 122-40-7

6,10-Dimethyl-3,5,9-undecatrien-2-

one

141-10-6 Amylcinnamyl alcohol 101-85-9

Diphenylamine 122-39-4 Benzyl alcohol 100-51-6

Ethyl acrylate 140-88-5 Benzyl salicylate 118-58-1


14

Fig leaf, fresh and preparations 68916-52-9 Cinnamyl alcohol 104-54-1

trans-2-Heptenal 18829-55-5 Cinnamal 104-55-2

trans-2-Hexenal diethyl acetal 67746-30-9 Citral 5392-40-5

trans-2-Hexenal dimethyl acetal 18318-83-7 Coumarin 91-64-5

Hydroabietyl alcohol 13393-93-6 Eugenol 97-53-0

4-Ethoxy-phenol 622-62-8 Geraniol 106-24-1

6-lsopropyl-2-

decahydronaphthalenol

34131-99-2 Hydroxy-citronellal 107-75-5

7-Methoxycoumarin 531-59-9 Hydroxy-methylpentylcyclohexene

carboxaldehyde

31906-04-4

4-Methoxyphenol 150-76-5 Isoeugenol 97-54-1

4-(p-Methoxyphenyl)-3-butene-2-

one

943-88-4 Oakmoss extracts 90028-68-5

1-(p-Methoxyphenyl)-1-penten-3-

one

104-27-8 Treemoss extracts 90028-67-4

Methyl trans-2-butenoate 623-43-8

In addition, the names of the following (Table 6) allergenic fragrances shall be listed on the toy, in an

affixed label, on the packaging or in an accompanying leaflet, if added to a toy, as such, at

concentrations exceeding 100 mg/kg in the toy or components.

Table 6. Allergenic substances that shall be listed if added to a toy at concentrations exceeding 100mg/kg.

Nº Name of the allergenic fragrance CAS number

(1) Anisyl alcohol 105-13-5

(2) Benzyl benzoate 120-51-4

(3) Benzyl cinnamate 103-41-3

(4) Citronellol 106-22-9

(5) Farnesol 4602-84-0

(6) Hexyl cinnamaldehyde 101-86-0

(7) Lilial 80-54-6

(8) d-Limonene 5989-27-5

(9) Linalool 78-70-6

(10) Methyl heptine carbonate 111-12-6

(11) 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one 127-51-5

2.6. Cosmetics Directive 76/768/EC

The main objective of the Cosmetics Directive is to guarantee that the cosmetic products within the

European market are not dangerous to human health under normal or foreseeable conditions of use.

The Directive includes rules on ingredients and composition of the cosmetics products, on the

information to be presented in the label and on the marketing surveillance and animal testing.

The Directive determines the list of substances which are prohibited in the composition of cosmetic

products (Annex II) and the substances which are subject to restrictions or specific conditions of use


15

(Annex III). The Directive also contains lists of authorized colourings (Annex IV), preservatives (Annex

VI) and UV filters (Annex VII).

In the frame of the Directive a database – ‘CosIng’: Cosmetic ingredients database (6) - was

developed with information on cosmetic ingredients contained in the:

"Cosmetics Directive" 76/768/EEC (Cosmetics Directive), as amended;

Inventory of Cosmetic Ingredients, as amended; and

Opinions on cosmetic ingredients of the Scientific Committee for Consumer Safety

‘CosIng’ also allows for search for the relevant CAS, ELINCS or EINECS numbers.

‘CosIng’ includes all data since the adoption of the Cosmetics Directive in 1976. Therefore the current

data are mentioned as "active" and the historical data as "not active". However, references to

scientific opinions of the Scientific Committee for Consumer Safety are restricted to those published

on the internet.

This Directive should be replaced by Regulation (EC) No 1223/2009 from 11 July 2013 (7), which

details are presented next.

2.7. Regulation (EC) Nº 1223/2009 on Cosmetic Products

From 11 July 2013, this Regulation will replace the “Cosmetics Directive” which until now ensured

that products circulate freely whilst guaranteeing a high level of protection for consumers. The

provisions of the Regulation aim at ensuring that consumers’ health is protected and that they are

well informed by monitoring the composition and labelling of products. The Regulation also provides

for the assessment of product safety and the prohibition of animal testing.

The Annexes of this Regulation give a list of prohibited substances (Annex II) or restricted substances

(Annex III) with respect to use in cosmetic products. Certain colorants (other than those in Annex IV),

preservatives (other than those in Annex V) and UV-filters (other than those in Annex VI) are also

prohibited.

The Regulation prohibits the use of substances recognized as carcinogenic, mutagenic or toxic for

reproduction (CMR), apart from exceptional cases. It provides for a high level of protection of human

health where nanomaterials are used in cosmetic products.

From the 1328 list of substances prohibited in cosmetic products, some of them are presented next

(Table 7).

Table 7. Some of the substances prohibited in cosmetic products (part of Annex II of (EC) Nº 1223/2009).

Ref. Nº Substance identification

Chemical name/INN CAS number EC number


16

38 Anthracene oil 120-12-7 204-371-1

47 Benzene 71-43-2 200-753-7

612 Benzo[def]chrysene (benzo[a]pyrene) 50-32-8 200-028-5

627 Coal liquids, liq. solvent extn. soln., if they contain > 0.005

% w/w benzo[a]pyrene

94114-47-3 302-682-8

629 Paraffin waxes (coal), brown-coal high-temp. tar, carbon-

treated, if they contain > 0.005 % w/w benzo[a]pyrene

97926-76-6 308-296-6

632 Absorption oils, bicyclo arom. and heterocylic hydrocarbon

fraction, if they contain > 0.005 % w/w benzo[a]pyrene

101316-45-4 309-851-5

633 Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar

pitch-polyethylene polypropylene pyrolysis-derived, if they

contain > 0.005 % w/w benzo[a]pyrene

101794-74-5 309-956-6

637 Dibenz[a,h]anthracene 53-70-3 200-181-8

638 Benz[a]anthracene 56-55-3 200-280-6

639 Benzo[e]pyrene 192-97-2 205-892-7

640 Benzo[j]fluoranthene 205-82-3 205-910-3

675 Dibutyl phthalate 84-74-2 201-557-4

677 bis(2-Ethylhexyl) phthalate (Diethylhexyl phthalate) 117-81-7 204-211-0

1167 Naphthalene 91-20-3 202-049-5

There is also a list of 256 substances which are subject to restrictions. Again only the priority

compounds are presented (Table 8).


Table 8. Some of the substances allowed but subject to restrictions (part of Annex III of (EC) Nº 1223/2009).

Ref.

Nº

Substance identification Restrictions Wording of

conditions of use

and warnings

Chemical

name/INN

Name of

Common

Ingredients

Glossary

CAS

number

EC

number

Product

type, body

parts

Maximum

concentration in

ready for use

preparation

Other

13 Formaldehyde [2] Formaldehyde 50-00-0 200-001-8 Nail

hardening

products

5 % (as

formaldehyde)

For purposes other than inhibiting the

development of micro-organisms in the

product. This purpose has to be

apparent from the presentation of the

product

Protect cuticles

with grease or oil

Contains

formaldehyde [3]

78 (2E) - 2,6-

Octadien-1-ol,

3,7-dimethyl-,

Geraniol 106-24-1 203-377-1 The presence of the substance must be

indicated in the list of ingredients

referred to in Article 19(1)(g) when its

concentration exceeds 0.001 % in

leave-on products and 0.01 % in rinse-

off products

84 1,6-Octadien-3-ol,

3,7-dimethyl-

Linalool 78-70-6 201-134-4 The presence of the substance must be





off products

88 (4R)-1-Methyl-4-

(1-methylethenyl)

cyclohexene

Limonene 5989-27-5 227-813-5 The presence of the substance must be





off products

[2] For use as preservative, see Annex V of the (EC) Nº 1223/2009 [3] Only if the concentration exceeds 0.05%


18

Concerning the list of preservatives allowed in cosmetic products, formaldehyde can be used but

with restrictions (Table 9).

Table 9. Some of the preservatives allowed but subject to restrictions (part of Annex V of (EC) Nº 1223/2009).

Ref.

Nº

Substance identification Restrictions

Chemical

name/INN

Name of

Common

Ingredients

Glossary

CAS

number

EC

number

Product

type,

body

parts

Maximum

concentration

in ready for

use

preparation

Other

5 Formaldehyde,

paraformalde

hyde [3]

Formaldehyde

Paraformalde

hyde

50-00-0,

30525-89-4

200-001-8 Oral

products

Other

products

0.1 % (free

formaldehyde)

0.2 % (free

formaldehyde)

Not to be used in

aerosol

dispensers

(sprays)

[3] For use other than as a preservative, see Annex III of the (EC) Nº 1223/2009

Also, all finished products containing formaldehyde or substances in the Annex V of (EC) Nº

1223/2009 which release formaldehyde must be labelled with the warning "contains formaldehyde"

when the concentration of formaldehyde in the finished product exceeds 0.05%.

2.8. EU Detergents Legislation

This regulation has been in force since 2005, when it replaced various earlier legislative measures.

Regulation (EC) Nº 648/2004 ensures the free circulation of detergents and of surfactants for

detergents on the internal market while at the same time providing, inter alia, a high level of

protection to the environment by laying down requirements for the ultimate biodegradability of

surfactants used in detergents. It requires that surfactants used in detergents meet stringent

biodegradation criteria. Regulation (EU) Nº 259/2012 has also the objective of protection of the

environment by reducing eutrophication caused by phosphorus in detergents used by consumers.

The health of users/consumers is also envisaged by this regulation by the obligation of information of

presence of allergenic substances in concentrations exceeding 0.01% w/w (list adopted from

cosmetic directive) on the label of packaging.

Regulation (EU) No 259/2012 of the European Parliament and of the Council of 14 March

2012 amending the Regulation (EC) No 648/2004 as regards the use of phosphates and other

phosphorus compounds in consumer laundry detergents and consumer automatic

dishwasher detergents (8)

Regulation (EC) No 551/2009 of 25 June 2009 amending Regulation (EC) No 648/2004 on

detergents, in order to adapt Annexes V and VI thereto (surfactant derogation)

Regulation (EC) No 907/2006 of 20 June 2006 amending Regulation (EC) No 648/2004 on

detergents, in order to adapt Annexes III and VII thereto

Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March

2004 on detergents consolidated version (27/06/2009)


19

Tiered approach guidance document - Methodology for the tiered approach to testing in the

context of Annex IV of Regulation (EC) No 648/2004 - Commission Recommendation

C/2005/5677 of 23 December 2005.

List of the 26 allergenic substances which must be labelled on the packaging of detergents if

added at concentrations exceeding 0.01% w/w - see Directive 2003/15/EC (7th amendment

to Directive 76/768/EEC, Annex III, part I) on the Cosmetics website / Legislation updates:

o Amyl cinnamal

o Benzyl alcohol

o Cinnamyl alcohol Amyl cinnamal

o Benzyl alcohol

o Cinnamyl alcohol

o Citral

o Eugenol

o Hydroxycitronellal

o Isoeugenol

o Amylcinnamyl alcohol

o Benzyl salicylate

o Cinnamal

o Coumarin

o Geraniol

o 4-(4-Hydroxy-4-methylpentyl)-3-cyclohexenecarboxaldehyde

o Anisyl alcohol

o Benzyl cinnamat

o Farnesol

o 2-(4-tert-Butylbenzyl)-propionaldehyde

o Linalool

o Benzyl benzoate

o Citronellol

o Hexyl cinnamaldehyde

o D-Limonene

o Methyl heptin carbonate

o 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one

o Oak moss extract (EVERNIA PRUNASTRI EXTRACT)

o Treemoss extract (EVERNIA FURFURACEA EXTRACT)

Instructions concerning the information that should be passed to the consumer are

presented in the “Ingredient Publication Guidance”:

“Ingredient Publication Guidance:

The manufacturer is required to make available to the public at large, on a website, a

simplified version of the ingredient datasheet. In this case it is recommended that ingredients

be listed in the order of their concentration in the product, e.g. highest to lowest ingredient

concentration. Any allergenic fragrances that are subject to package labelling requirements

under Annex VII.A (i.e. if at concentrations exceeding 0.01% by weight) should also be listed

on the website if they are included in the product.


20

For each ingredient listed the INCI name should be given, if available. Where not available,

then the European Pharmacopoeia name, if available, should be given. If neither name is

available, then the common chemical or the IUPAC name should be used.

Manufacturers must make available on a website the public list of ingredients. The location of

the website is not prescribed and the manufacturer is free to choose. It is recommended that

the choice is made on the basis of logical access, e.g. via a website dedicated to the product

or the manufacturer. The manufacturer can also consider making joint arrangements with

other manufacturers, e.g. via their trade association, with a view to producing a general

detergent product ingredient database website.

A website is required and not optional. Its address should appear on the label. This last point

is not strictly required at this stage, but it is strongly recommended in view of a foreseen

future amendment along those lines that will be discussed after entry into force of this

regulation. The information on the website must be kept up-to-date. However, when a

website is in the course of development or being upgraded, consumers should be able to

acquire the information by enquiring from the telephone number that is on the label.

That manufacturers must ‘make available’ on a website should be interpreted as ‘display’ on

a website (free of charge) the public list of ingredients.

In view of a foreseen future amendment to the current wording of Annex VII D that will be

discussed after entry into force of the Regulation and that will confirm the possibility to use

only the INCI names for each ingredient, a link must be provided to the Commission’s website

on cosmetics that provides a correspondence table between INCI names and CAS numbers.

This website address is: http://pharmacos.eudra.org/F3/inci/index.htm.

Information regarding a product should be retained on the website for two years following

the last production of that product. The manufacturer should also consider the means by

which products and their variants will be linked to the website information.”

2.9. European EcoLabel

The EU Ecolabel was established in 1992 by the European Commission to encourage businesses to

market products and services that meet high standards of environmental performance and quality.

The EU Ecolabel is awarded according to environmental criteria agreed on by experts, industry,

consumer organizations and environmental NGOs at European level.

EU Ecolabel criteria consider the whole life cycle of a product from the extraction of raw materials,

through manufacture, packaging, distribution, use and disposal of the product. Criteria have been

formulated for 25 non-food and non-medical product groups that are reviewed every 3-5 years to

keep up with technological innovation:

All purpose cleaners Bed mattresses

Copying and Graphic Paper Dishwashing Detergents

Footwear Hand Dishwashing Detergents

Hard Floor Coverings Indoor Paints & Varnishes

Laundry Detergents Light Bulbs

Soil Improvers Textile Products

Tissue Paper TVs

Lubricants Personal Computers


21

Soaps & Shampoos Growing Media

Heat Pumps Outdoor Paints & Varnishes

Soft (Textile) Floor Coverings Wooden Floor Coverings

Wooden Furniture Tourist Accommodation Services

Camp Site Services

The EU Ecolabel is a voluntary scheme, which means that producers, importers and retailers can

choose to apply for the label for their products. When developing EU Ecolabel criteria for products,

the focus is on the stages where the product has the highest environmental impact, and this differs

from product to product.

Next, the criteria established for the categories with more interest for EPHECT project highlighting

the criteria related with exposure and human health, are presented.

2.9.1. All purpose cleaners

The objectives of the established criteria (9) are:

the reduction of environmental impact by limiting the quantity of harmful ingredients, by

reducing the quantity of detergent used and by reducing packaging waste;

the reduction or prevention of risks for the environment and for human health related to the

use of hazardous substances;

the information that will enable the consumer to use the product in the way that is efficient

and minimises environmental impact.

Concerning the dangerous, hazardous or toxic substances or preparations, there are some limits

/restrictions established:

Ingredients that shall not be included in the product (either as part of the formulation or as a part of

any preparation included in the formulation): alkylphenol ethoxylates and derivatives, EDTA and its

salts, NTA, nitromusks and polycyclic musks

Quaternary ammonium salts that are not readily biodegradable shall not be used (either as part of

the formulation or as a part of any preparation included in the formulation)

Ingredients (substance or preparation) that exceeds 0.01% by weight of the final product and with

any of the following risk phrases, shall not be included in the product:

R31(contact with acid liberates toxic gases), R40 (limited evidence of a carcinogenic effect),

R45 (may cause cancer), R46 (may cause heritable genetic damage), R49 (may cause cancer

by inhalation), R68 (possible risks of irreversible effects), R60 (may impair fertility), R61 (may

cause harm to the unborn child), R62 (possible risk of impaired fertility) R63 (possible risk of

harm to the unborn child), R64 (may cause harm to breastfed babies),…and others related

with environment

Sensitising substances: The concentration of any substance or ingredient classified with risk phrases

R42 (may cause sensitisation by inhalation) and/or R43 (may cause sensitisation by skin contact) shall

not exceed 0.1% by weight of the final product


22

Volatile Organic Compounds: The product shall not contain more than 10% (by weight) of volatile

organic compounds with a boiling point lower than 150ºC.

Phosphorus:

For all purpose cleaners – the total phosphorus content shall not exceed 0.02 g/ functional

unit.

For cleaners for sanitary facilities - the total phosphorus content shall not exceed 1.0 g/ 100 g

of product

Window cleaning products – must not contain phosphorus

The concentration of biocides in the final product shall not exceed the maximum authorised

concentration in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of

the Member States relating to cosmetic products and its subsequent amendments.

The products should also comply with obligations concerning packaging, information to consumer.

2.9.2. Hand Dishwashing Detergents


Reduction of discharges of toxic or otherwise polluting substances into the aquatic

environment,

Reduction or prevention risks to health or the environment related to the use of hazardous

substances,

Minimisation of packaging waste,

Provide information that will enable the consumer to use the product in the way that is

efficient and minimising environmental impact.



The following substances shall not be included in the product if exceeding 0.01% by weight of the

final product: Alkyl phenol ethoxylates (APEOs) and derivatives thereof, EDTA (ethylene-diamine-

tetraacetic acid) and its salts, 5-Bromo-5-nitro-1,3-diol, Diazolinidylurea, Formaldehyde, Sodium

hydroxyl methyl glycinate, Nitro-musks and polycyclic musks.

Quaternary ammonium salts that are not readily biodegradable must not be used in quantities

exceeding 0.01% by weight of the final product.

The product does not contain substances exceeding 0.01% by weight of the final product meeting the

criteria for classification with the hazard statements or risk phrases in accordance with Regulation

(EC) No 1272/2008 listed in the Criteria document nor does it contain substances referred to in

Article 57 of Regulation (EC) No 1907/2006.

Concerning fragrances:


23

Any substances added to the product as a fragrance must have been manufactured and/or handled

in accordance with the code of practice of the International Fragrance Association. The code can be

found on IFRA website (http://www.ifraorg.org).

Fragrance substances subject to the declaration requirement provided for in Regulation (EC) No

648/2004 on Detergents and which are not already excluded by criterion 3(c) and (other) fragrance

substances classified H317/R43 (May cause allergic skin reaction) and/or H334/R42 (May cause

allergy or asthma symptoms or breathing difficulties if inhaled) must not be present in quantities >

0.01% (> 100 ppm) per substance.

2.9.3. Soaps and Shampoos


the reduction of water pollution both by limiting the quantity of potentially harmful

ingredients and the total toxic load of the product,

the minimisation of waste production by reducing the amount of packaging,

the reduction or prevention of potential risks for the environment related to the use of

hazardous substances.



The product shall not be classified with any of the following risk phrases according to Directive

67/548/EEC: R50-53, R51-53, and R52-53. Rubbing/abrasive agents in hand cleaning agents are not

included.

No constituent substance exceeding 0.01% by weight of the final product must be classified as

carcinogenic (Carc), mutagenic (Mut) or toxic to reproduction (Rep) including rules for self-

classification class III.

Fragrances must have been manufactured, handled and applied following the code of practice of the

International Fragrance Association.

Preservatives must not release substances classified as carcinogenic (Carc), mutagenic (Mut) or toxic

to reproduction (Rep) including rules for self-classification class III.

Additives contained in packaging must:

not release substances classified as carcinogenic (Carc), mutagenic (Mut) or toxic to

reproduction (Rep) including rules for self-classification class III.

not be based on Cd or Hg or compounds with these elements.


24

2.10. Green Public Procurement

Green Public Procurement (GPP) (12) is defined in the Communication (COM (2008) 400) “Public

procurement for a better environment” as "a process whereby public authorities seek to procure

goods, services and works with a reduced environmental impact throughout their life cycle when

compared to goods, services and works with the same primary function that would otherwise be

procured.”

GPP is a voluntary instrument, which means that Member States and public authorities can

determine the extent to which they implement it.

Public authorities are major consumers in Europe: they spend approximately 2 trillion euros annually,

equivalent to some 19% of the EU’s gross domestic product. By using their purchasing power to

choose goods and services with lower impact on the environment, they can make an important

contribution to sustainable consumption and production.

The basic concept of GPP relies on having clear, verifiable, justifiable and ambitious environmental

criteria for products and services, based on a life-cycle approach and scientific evidence base. The

GPP criteria are based on data from an evidence base, on existing Ecolabel criteria and on

information collected from stakeholders of industry, civil society and Member States. Since 2008, the

Commission has developed 19 common GPP criteria:

Copying and graphic paper Cleaning products and services

Office IT equipment Construction

Transport Furniture

Electricity Food and Catering services

Textiles Gardening products and services

Windows, Glazed Doors and Skylights Thermal insulation

Hard floor-coverings Wall Panels

Combine Heat and Power (CHP) Road construction and traffic signs

Street lighting and traffic signals Mobile phones

Indoor lighting

The only group in the scope of EPHECT is “Cleaning products and Services”. In terms of products, four

categories of products are covered, in line with those covered by the EU Ecolabel:

All purpose cleaners, sanitary cleaners and window cleaners

Detergents and rinse aids for dishwashers

Hand dishwashing detergents

Laundry detergents and pre-treatment stain removers for washing machines.

The criteria are very similar to those of Ecolabel already presented.


25

2.11. CEN Standards

The European Committee for Standardization (CEN) was officially created as an international non-

profit association based in Brussels on the 30 October 1975.

CEN is a major provider of European Standards and technical specifications (13). It is the only

recognized European organization according to Directive 98/34/EC for the planning, drafting and

adoption of European Standards in all areas of economic activity with the exception of electro

technology (CENELEC) and telecommunications (ETSI).

CEN concentrates most of its efforts on one major deliverable: the European Standard (EN). This

document shall be given the status of national standard in all CEN member countries, who must also

withdraw any conflicting national standards. With one common standard in all these countries, a

product can reach a far wider market with much lower development and testing costs. European

Standards help build a European Internal Market for goods and services and position Europe in the

global economy. Besides European Standards, CEN produces other deliverables with specific

characteristics and objectives. They are the Technical Specifications (TS), Technical Reports (TR),

Guides and Workshop Agreements (CWA).

A House full of standards:

The CEN work is organized in Sectors, being one of them the Consumer Products. Within this sector

there are several Technical Committees (TC) that prepare specific standards. The list of TC is

presented in next table.


26

Table 10. Work programme of Consumer Products Technical Committees

CEN/TC 52 Safety of toys

CEN/TC 136 Sports, playground and other recreational equipment

CEN/TC 207 Furniture

CEN/TC 222 Feather and down as filling material for any article, as well as finished articles filled

with feather and down

CEN/TC 248 Textiles and textile products

CEN/TC 252 Child use and care articles

CEN/TC 263 Secure storage of cash, valuables and data media

CEN/TC 279 Value Management - Value analysis, functional analysis

CEN/TC 281 Appliances, solid fuels and firelighters for barbecuing

CEN/TC 289 Leather

CEN/TC 309 Footwear

CEN/TC 332 Laboratory equipment

CEN/TC 333 Cycles

CEN/TC 392 Cosmetics

CEN/TC 398 Child Protective Products

CEN/TC 401 Reduced Ignition Propensity Cigarettes

CEN/TC 402 Domestic Pools and Spas

CEN/TC 416 Project Committee - Health Risk Assessment of Chemicals

The Technical Committees with more interest for EPHECT project are CEN/TC 52 (Safety of toys) and

CEN/TC 392 (Cosmetics). There is a series of standards already prepared by TC 52, being the more

relevant for EPHECT presented in table 11. Concerning the standards prepared by TC 392 it can be

seen that are focused in the evaluation of sun protection properties and microbiological control, not

existing evaluation of chemical content or release.


27

Table 11. Example of standards already prepared by CEN/TC 52 (Safety of toys)

CEN/TC 52 Safety of toys

EN 71-10:2005: Safety of toys - Part 10: Organic chemical compounds - Sample

preparation and extraction

EN 71-11:2005: Safety of toys - Part 11: Organic chemical compounds - Methods of

analysis

EN 71-3:1994/AC:2002: Safety of toys - Part 3: Migration of certain elements

EN 71-7:2002: Safety of toys - Part 7: Finger paints - Requirements and test methods

EN 71-8:2011: Safety of toys - Part 8: Activity toys for domestic use

EN 71-9:2005+A1:2007: Safety of toys - Part 9: Organic chemical compounds –

Requirements

EN 71-10:2005: Safety of toys - Part 10: Organic chemical compounds - Sample

preparation and extraction

EN 71-11:2005: Safety of toys - Part 11: Organic chemical compounds - Methods of

analysis

However, some other Technical Committees are of interest for some of the consumer products

studied under EPHECT project, as TC 369 for Candles, TC 421 for Emission safety of combustible air

fresheners and similar products, SS H99 for “Products for household and leisure use –

Undetermined” and TC 276 for Surface active agents, with impact on Detergents and Cosmetics. The

list of standards with interest for EPHECT is presented in table 12:

Table 12. Example of standards already prepared by other Technical Committees (TC 369, TC 421, SS H99 and TC 276)

CEN/TC 369 Candles

EN 15494:2007 – Candles – Product Safety Labels

EN 15493:2007 – Candles – Specification for Fire Safety

EN 15426:2007 – Candles – Specification for Sooting Behaviour

CEN/TC 421 Emission safety of combustible air fresheners and similar products

Emission safety of combustible air fresheners - Test methods – under drafting

Emission safety of combustible air fresheners - Methodology for the assessment of test

results and application of recommended emission limits – under drafting


28

Emission safety of combustible air fresheners - User safety information – under

drafting

CEN/SS H99 Products for household and leisure use - Undetermined

EN 14059:2002 - Decorative oil lamps - Safety requirements and test methods

CEN/TC 276 Surface active agents

EN 12139:1999 -Surface active agents - Determination of the total polyethylene glycol

content of non-ionic surface active agents (EO adducts) by HPLC/GPC

EN 12582:1999 - Surface active agents - Determination of the polyethylene glycol

content according to molar mass in non-ionic surface active agents (ethoxylated) by

HPLC/ELSD

EN 12974:1999 - Surface active agents - Determination of the 1,4-dioxane content in

alkyl-ethoxy-sulfate products by GLC/head space procedure

EN 13268:2001/AC:2002 - Surface active agents - Determination of ethylene oxide and

propylene oxide groups in ethylene oxide and propylene oxide adducts

EN 13320:2002 - Surface active agents - Gas chromatographic trace determination of

free ethylene oxide in ethoxylates

EN 14667:2005 - Surface active agents - Determination of low boiling solvents in liquid

formulations - Gas chromatographic method

EN 14668:2005/AC:2006 - Surface active agents - Determination of quaternary

ammonium surface active agents in raw materials and formulated products -

Potentiometric two-phase titration method

EN 14981:2006 - Surface active agents - Determination of content of high boiling

solvents in liquid detergents by GLC

There are also some general Standards that are important in EPHECT context, more specifically the

related with Environmental Management (S26). The EN ISO 14000 series of standards provide

guidelines for companies, telling them how they can provide product-specific product information on

a voluntary basis and, at the same time, satisfy the customers need for information. Some of those

standards are related with the organisation of the company, others are specific of the products.

Concerning the first topic (company organisation) there are available:

14001 series of standards - supports an organisation in the establishment and optimisation of

an environmental management system

19011 series of standards - contains instructions for the performance of environmental

audits


29

14030 series of standards contains instruction for the selection and application of indicators

for evaluation of an organisation's environmental performance

14063 series of standards - Contains environmental communication guidelines

Concerning the product:

- 14020 series of standards - contains instruction for product labelling and identification

- 14040 series of standards contains instruction for the preparation of life cycle assessments

The list of some those published standards is presented in table 13.

Table 13. Example of standards already prepared by CEN/SS S26 Environmental management

CEN/SS S26 Environmental management

CEN Guide 4:2008 - Guide for addressing environmental issues in product standards

EN ISO 14001:2004/AC:2009 - Environmental management systems - Requirements

with guidance for use (ISO 14001:2004/Cor 1:2009)

EN ISO 14004:2010 - Environmental management systems - General guidelines on

principles, systems and support techniques (ISO 14004:2004)

EN ISO 14006:2011 - Environmental management systems - Guidelines for

incorporating ecodesign (ISO 14006:2011)

EN ISO 14015:2010 - Environmental management - Environmental assessment of sites

and organizations (EASO) (ISO 14015:2001)

EN ISO 14020:2001 - Environmental labels and declarations - General principles (ISO

14020:2000)

EN ISO 14021:2001/A1:2011 - Environmental labels and declarations - Self-declared

environmental claims (Type II environmental labelling) - Amendment 1 (ISO

14021:1999/Amd 1:2011)

EN ISO 14024:2000 - Environmental labels and declarations - Type I environmental

labelling - Principles and procedures (ISO 14024:1999)

EN ISO 14025:2010 - Environmental labels and declarations - Type III environmental

declarations - Principles and procedures (ISO 14025:2006)

EN ISO 14031:1999 - Environmental management - Environmental performance

evaluation - Guidelines (ISO 14031:1999)

EN ISO 14040:2006 - Environmental management - Life cycle assessment - Principles

and framework (ISO 14040:2006)


30

EN ISO 14044:2006 - Environmental management - Life cycle assessment -

Requirements and guidelines (ISO 14044:2006)

EN ISO 14045:2012 - Environmental management - Eco-efficiency assessment of

product systems - Principles, requirements and guidelines (ISO 14045:2012)

EN ISO 14050:2010 - Environmental management - Vocabulary (ISO 14050:2009)

2.12. EU-LCI HARMONIZATION

A strategy used to assess product emissions from a health point of view is a single compound evaluation by comparison with the LCI “Lowest Concentration of Interest” values. The background of the LCI-approach was presented in ECA Report no. 18 on "Evaluation of VOC Emissions from Building Products – Solid Flooring Material" (1997). LCI is defined in that report as the lowest concentration above which, according to best professional judgment, the pollutant may have some effect on people in the indoor environment.

Procedures that provide a transparent system for setting EU-LCI values have been further developed/revised in the German AgBB scheme and in the French AFSSET (now ANSES) protocol for the health related evaluation of VOC emissions from building products. The procedures and the main differences between these two approaches are outlined in the ECA report no. 27 (2012). For several compounds there are significant differences in the LCIs values derived in the German and French systems mostly due to differences in the decision tree used for setting the LCI values. These discrepancies underlined the necessity of re‐evaluating/revising the criteria for deriving LCI values and devising a harmonized procedure for establishing a European list of compounds and their associated LCI values.

The consensus on the way forward in harmonising the health based evaluation of emissions from building products in Europe based on the LCI concept was achieved in late 2010 during a Workshop organised by the European Commission’s Joint Research Centre (EC-JRC, 2010). Subsequently, in 2011 a preparatory working group on EU-LCI comprising toxicologists and experts in emission testing and product labelling was established by EC-JRC (as part of the PILOT INDOOR AIR MONIT administrative arrangement no.SI2.582843 with DG SANCO) to work on the development of a harmonised EU- LCI concept and procedure for establishing EU-LCI values. The EU-LCI harmonization work is considered an integral part of the harmonisation framework for indoor products labelling schemes in the EU which has potential for wide application across Europe, ensuring better protection of the health of European citizens from hazardous substances in indoor materials. The starting EU-LCI list contains around 170 VOCs commonly detected in emission tests of building

materials used indoors. The LCI values used in the German and French systems for the compounds of

interest to the EPHECT project are presented in next table. It should be noted that some compounds

object of study in EPHECT (e.g. acrolein and benzopyrene) are not part of the EU-LCI list as this latter

contains only compounds emitted from building materials and not from other consumer products

emitted indoors.


31

Compound CAS LCI (g/m

3)

(ECA) 1997 NIK (g/m

3)

(AgBB) 2012 CLI (g/m

3)

(AFSSET) 2009

Benzene 71-43-2 2.5* 1 1

Toluene 108-88-3 1000 1900 300

Xylenes 1330-20-7 1000 2200 200

Styrene 100-42-5 70 860 250

Naphthalene 91-20-3 500 5 10

Limonene 138-86-3 1000 1500 450

-pinene 80-56-8 1000 1500 450

Geraniol 106-24-1 1500

a-terpineol 98-55-5 1500

Linalool 78-70-6 1500

Formaldehyde 50-00-0 10 ---- 10

Glutaraldehyde 111-30-8 2 0.08

Acetaldehyde 75-07-0 40 VVOC 200

Octaméthylcyclotetrasiloxane 556-67-2 1200 1200

Decamethylcyclopentasiloxane (D5) 541-02-6 1500

Dodecamethylcyclohexasiloxane (D6) 540-97-6 1200

*Benzene as a carcinogenic compound is evaluated after 24 hours and 28 days, being the limit value fixed according the lifetime unit risk (LUR).

The harmonisation framework for health based evaluation of indoor emissions from construction

products in the European Union using the EU-LCI concept along a list with interim EU-LCI values is

expected to be published in autumn 2013 as ECA report 29.

It is recommended to extend the EU-LCI list to contain besides compounds emitted from

construction products also compounds emitted indoors from consumer products as those identified

and reported by EPHECT.

Chapter 3 National Policies in Europe

32

3. NATIONAL POLICIES IN EUROPE

European countries are obliged to transpose EC Directives into their national legislation. In addition,

they can be object of judicial action by the EC if they do not do it on time. So, all the Directives

presented in the previous chapter can be found in the present in the national legislation. As stated in

the report “Product Policy in the Context of the Indoor Environment Quality” (15) European

Countries make very rarely their own initiatives. This report identifies some policies at national level

that can be resumed here:

- In Sweden the use of chlorinated solvents (dichloromethane, tetrachloroethane,

tetrachloromethane, trichloroethane and trichloroethylene) in consumer products is banned.

- Denmark, in 1995, adopted a tax on the use of the most common chlorinated solvents

(tetrachloroethylene, trichloethylene and dicloromehane)

- Germany employed restrictions concerning emissions of trichloroethylene and

tetrachloroethene.

- Norway implemented a tax per kilo on both tricholoethylene and tetrachhloroethene.

It will be desirable to identify all the regulations that can control the presence of harmful substances

on consumer products but, at this stage, it is not possible to have this information.

Sometimes Member States can be the precursors of future EC directives. It is the case, for example,

of the voluntary label Blue Angel that was created in 1978 by the federal and regional governments

of Germany. Also, the European EcoLabel, was in several cases improved by the own countries, that

created in parallel their own label with a different logo, with new categories of products to be

labelled, or adding new criteria. Those examples are presented next.

3.1. France

NF-ENVIRONNEMENT POUR LES PRODUITS D’ENTRETIENT

The NF Environnement (16), the French label set up by AFNOR and ADEME, attests the conformity of

products and/or services to specified requirements according specific criteria for every category.

These criteria are the result of negotiations between representatives of manufacturers, consumers,

environmental protection and distributor associations and public authorities. The specificity of this

label is to consider the environmental impacts throughout the product life cycle. The tag may be


33

affixed to the products and services that meet the criteria specified in the certification standards for

each grade.

Are temporarily excluded from the scope of this brand pharmaceuticals, food products and

automotive. Until now there are 23 categories of products or services which may be eco-labelled by

NF:

Furniture

Electrical appliances

- Electric coffee filter for domestic use

Bricolage

- Paints, varnishes and related products

- Universal colorants

- Adhesives for floor coverings

- Profiles for decoration and furnishing for use by consumers

- Paint coatings

Office

- Laser print cartridges

Gardening

- Individual garden composters

Stationery/Paper

- Mailers and postcards

- Notebooks

- Adhesives for stationary

- Writing instruments

Care products

- Cleaning Products

Professional products

- Road marking products

- Absorbent for road use and industry

- Blocks of lighting

Services

- Services of mechanical renovation of automotive items

Domestic life

- Auxiliary mechanical washing

- Coffee filters

- Cat litter

- Garbage bags, bags for the collection and pre-collection of waste

- Carrier Bags

In the frame of EPHECT project the only category with interest is “cleaning products”, but this applies

only to the routine cleaning of interior surfaces and/or exterior of automotive sector, mechanical

(including tools used in the construction sector) and maritime sector. This category excludes wipes,

the products of type "polishing" and the household detergents that should be certified by the

European Ecolabel. For this reason no specific details are presented.


34

3.2. Nordic countries

NORDIC ECOLABEL OR ‘SWAN’

The "Swan" symbol, as it is known in Nordic countries, is available for 65 product groups. The Swan

checks that products fulfil certain criteria using methods such as samples from independent

laboratories, certificates and control visits. Each Nordic country has local offices with the

responsibility for criteria development/control. In the next table the several products covered by

Nordic Swan are listed, being the products with more interest to EPHECT project presented in bold.

The criteria of some of those products will be presented in detail, highlighting of course the

compounds with special focus in the project. Detailed information of other categories can be

consulted and downloaded in the website (17).

Alternative dry cleaning Audiovisual equipment

Base module Batteries, Primary

Biofuel Pellets Candles

Car and boat care products Chemical building products

Chemical List Chemical module

Cleaning agents for use in the food industry Cleaning Products

Cleaning services Closed Toilet Systems

Coffee filters Compost bins

Computers Copy and printing paper

Cosmetic products De-icers

DID-list Dishwasher detergents

Dishwasher detergents for professional use Dishwashers

Disposable bags, tubes and accessories for

health care

Durable wood Alternative to conventionally

impregnated wood

Fabric cleaning products containing micro

fibres

Film forming floor care products

Floor coverings Fuel

Furniture and fitments Grease-proof Paper

Hand Dish wash Detergents Heat pumps

Hotels and youth hostels Imaging equipment

Indoor paints and varnishes Industrial cleaning and degreasing agents


35

Laundries/ Textile Services Laundry detergents and stain removers

Laundry detergents for professional use Lubricants

Machines for parks and gardens Outdoor furniture and playground equipment

Panels for the building, decorating and

furniture industry

Paper envelopes

Photographic developments services Printing Companies

Rechargeable batteries and battery chargers Refrigerators and freezers

Restaurants Sanitary Products

Small houses, apartment buildings and pre-

school buildings

Solid Bio fuel Boilers

Stoves Supermarket Grocery Stores

Textiles, skins and leather Tissue paper

Toner cartridges Toys

Washing machines Vehicle Tyres

Vehicle wash installations Windows and exterior doors

Writing Instruments

Candles

All candles can carry the Nordic Ecolabel if they meet the defined criteria. Some important aspects

are:

- Candles made with a high content of paraffin cannot receive the Nordic Ecolabel because the

content of renewable raw materials shall be at least 90% weight of the candle, and paraffin is

by definition not a renewable raw material.

- The Soot Index (according standard EN 15246) should be

o < 1.0 per hour (average value of 3 samples)

o < 2.0 per hour (individual result)

- The use of chemicals, substances, preparations, additives, lacquers and dyes containing more

than 0.01% by weight of substances with the risk phrases (R40, R42, R43, R45, R46, R49, R50,

R51, R53, R59, R60, R61, R62, R63, R68 – the same defined in Ecolabel) are prohibited

- None of the following heavy metals - Mercury, Lead, Cadmium, Zink, Copper, Nickel, Cobalt,

Antimony and Chrome - must be added to any part of the candle

- Aromatic solvents must not be used in the production of the candle (exception, the possible

paraffin fraction)

- Halogenated solvents must not be used in the production of the candle

- Total amount of organic solvents:

o the content must not exceed 1% by weight of the candle; or

o the concentration of TVOC measured in a test chamber for 24 h (ISO 16000-6) must

not exceed 1200 µg/m3


36

- Scented candles cannot receive the Nordic Ecolabel since criterion R13 prohibits fragrances

due to the risk of allergy

- Phthalates - the candle must not contain phthalates of any kind

- Azo dyes and azo lacquers that may cleave to any of the aromatic amines as for example 4-

aminodiphenyl, benzidine, 4-chloro-o-toluidine, 2-naphthylamine (see completed list in

Annex), in a concentration above 30 ppm shall not be used

- Tea lights can only be Nordic Ecolabelled if they are sold without cups or with cups that are

either biodegradable or can be used several times. Aluminium cups cannot be used several

times.

- Oil lamps are not regarded as candles in this connection and can therefore not receive the

Nordic Ecolabel

Cleaning products

The product group includes cleaning products intended for indoor, general and regular cleaning of

the following areas: fixed surfaces (floors, walls, ceilings, doors, tiles and windows), kitchen

equipment (for example tiles, work surfaces, kitchen machines, taps) and sanitary installations

(toilets, baths, showers, wash basins, taps). Some important criteria to EPHECT project are presented

next:

- The cleaning agent must not contain substances that are, or may split up substances that are

classified as carcinogenic (Carc) mutagenic (Mut) or reproduction toxic (Rep) with the

following risk phrases: R40 Limited evidence of a carcinogenic effect; R45 May cause cancer;

R46 May cause heritable genetic damage; R49 May cause cancer by inhalation; R60 May

impair fertility; R61 May cause harm to the unborn child; R62 Possible risk of impaired

fertility; R63 Possible risk of harm to the unborn child; R64 May cause harm to breast-fed

babies; R68 Possible risk of irreversible effects.

- The product must not contain substances classified as sensitising as R42 and/or R43. To

preservatives in the product with pH in the area 3.0-10 are given the following exception:

Preservatives assigned with the risk phrases R42 and/or R43 can be included in a

concentration less than 0.1% weight. However in spray products, preservatives assigned with

the risk phrase R42 cannot be included.

- If fragrance is added to the product, the guidelines issued by IFRA must be followed.

- Concerning fragrance, carcinogenic musk compounds, the following compounds must not be

present in the product: Musk xylene (CAS 81-15-2) Musk ambrette (CAS 83-66-9); Moskene

(CAS 116-66-5); Musk tibetine (CAS 145-39-1); Musk ketone (CAS 81-14-1); HHCB (CAS

114109-62-5, 114109-63-6, 1222-05-5, 78448-48-3 and 78448-49-4); AHTN (CAS 1506-02-1

and 21145-77-7).

- Substances listed in the table below (table 14) and/or fragrance substances classified as

allergenic as R42 and/or R43 must individually not be present in the product in quantities in

excess of 0.010 weight% (100 ppm). In refills for aerosol products, the substances mentioned

above may individually be present in concentrations below 0.1 weight% (1000 ppm) – only if

the recommended dilution gives a concentration below 0.01% (100 ppm).


37

Table 14. Substances with restrictions under Nordic Ecolabel Requirements (R14) for cleaning products

Compound CAS Compound CAS

Amyl cinnamal 122-40-7 Amylcinnamyl alcohol 101-85-9

Anisyl alcohol 105-13-5 Benzyl alcohol 100-51-6

Benzyl benzoate 120-51-4 Benzyl cinnamate 103-41-3

Benzyl salicylate 118-58-1 Cinnamal 104-55-2

Cinnamyl alcohol 104-54-1 Citral 5392-40-5

Citronellol 106-22-9 Coumarin 91-64-5

d-limonene 5989-27-5 Eugenol 97-53-0

Farnesol 4602-84-0 Geraniol 106-24-1

Hexyl cinnamaldehyde 101-86-0 Hydroxycitronella 107-75-5

Hydroxymethyl-phentylcyclo hexenecarboxaldehyde

31906-04-4 Isoeuenol 97-54-1

Liilal 80-54-6 Linalool 78-70-6

Methyl heptine carbonate 111-12-6 Gamma-methylionon 127-51-5

Oak moss extract 90028-68-5 Tree moss extract 90028-67-4

- The product must not be subject to classification as specified in the following table:

Table 15. Classification not allowed under Nordic Ecolabel requirements for cleaning products

Classification Associated hazard symbol and R phrases

Environmentally harmful N with R50, R50/53 or R51/53. R52, R53 or R52/53 without N.

Very toxic Tx (T+ in Norway)

Toxic T

Harmful to health Xn, exceptions: Professional products may be labels R20, R21 and/or R22 where the packaging is made in such a way that the user will not be in contact with the product.

Locally irritant Xi, exceptions: products may be R36, R37 and/or R38. Professional product may be R36, R37, R38 and/or R41.

Allergenic Xn with R42 or Xi with R43

Corrosive C as R34 and R35 Exceptions for professional products, and WC-products for consumers – if the classification is set because of ph.

Carcinogenic Carcinogenic R40, R45 and/or R49

Mutagenic Mut with R46 and/or R68

Reprotoxic Rep with R60, R61, R62, R63, R64 and/or R68

Explosive E

Extremely flammable Fx (F+ in Norway)

Highly flammable F

Fire hazard No symbol


38

Cosmetics products

All cosmetic products that are encompassed by Council Directive 76/768/EEC on cosmetics with

subsequent amendments and adaptations and Cosmetics Regulation 1223/2009/EG as, for example,

skin care products, hair care products, decorative cosmetics, perfumes and sanitary products, can be

Nordic Ecolabelled. Products within the remit of the Biocidal Products Directive (Directive 98/8/EC)

cannot be Nordic Ecolabelled.

3.3. Germany

BLUE ANGEL

The Blue Angel was created by the federal and regional governments in 1978 (18). The purpose of its

creation was, and still is, to promote products which have considerably better environmental

characteristics than comparable conventional goods. Today about 11,700 products and services in

circa 120 product categories carry the Blue Angel eco-label. These include paper products, furniture,

electrical devices and appliances, paint, varnish and lacquer, sanitary and hygiene products, as well

as products used in the horticultural and landscape gardening, building and interior design,

transportation and service sectors.

The categories with health based criteria with interest for EPHECT project are: textile toys, wooden

toys, textile cleaning and wood conservative agents. The criteria developed for wooden toys are

presented next. Details on other categories can be consulted and downloaded from the site

http://www.blauer-engel.de/en/products_brands/search_products/search_for_products.php.

Wooden Toys

Wooden toys can have environmental impact during their production, use and disposal or pose a risk

to children’s health. Hence, the requirements for the Blue Angel eco-label cover the entire life cycle

of wooden toys. They refer not only to the manufacture and the substances and materials used but

also to the period of use as well as to the disposal of used wooden toys and the packaging materials

of new wooden toys. The Environmental Label for Wooden Toys may be awarded to toys which -

beyond the legal provisions-:

- are manufactured in an environmentally friendly way; - do not pose a risk to the playing child’s health; and, - do not contain any hazardous substances that might well impede the recycling process.

Only timber from sustainable forestry shall be used for the manufacture. The use of low-emission

wood-based materials will be supported. The requirements with impact on use are presented next:

- Odour: The product may only have a material-specific odour. Such odour may be distinctive but not annoying. In addition, no technically avoidable odours may be emitted from volatile


39

components (e.g. solvents). Testing shall be done in accordance with SNV 19565110 in conjunction with DIN 1095511. The average evaluation of odour intensity must be < 3.

- Volatile Organic Compounds: The emissions of volatile organic compounds shall be quantified. The products shall not exceed the specific concentrations presented in Table 16 in conformity with the health risk assessment process for emissions of volatile organic compounds (VOCs) from building products developed by the Committee for Health- Related Evaluation of Building Products. The emissions of a wooden toy shall be determined in a test chamber with an area specific air flow rate of 1.0 m3/(m2.h).

Table 16. Limit values for Test Chamber Emission Measurements.

Substance Test Chamber Concentration; Final Value (3rd Day)

Formaldehyde 36 µg/m3 (0.03 ppm)

Other aldehydes15 (total) ≤ 40 µg/m3

CMT substances ≤ 1 µg/m3 per single value

- Non-Wooden materials and articles that can be placed into the mouth must additionally comply with the provisions of Directive 2005/84/EC and Regulation EC 1935/2004.

- Due to the way wooden toys are used they shall not exceed the migration values listed in Table 17:

Table 17. Migration limit values.

Element Symbol Migration Limit Values [mg/kg]

Antimony Sb 25

Arsenic As 10

Barium Ba 100

Lead Pb 10

Boron B 500

Cadmium Cd 3

Chromium (III) Cr 30

Mercury (inorganic) Hg 10

Selenium Se 30

Tin compounds (organic) Sn 10

- The lead content in the surface coating shall not exceed 50 mg/kg. - Nickel Content – the Directive 94/27/EC23 shall be applied with regard to the dermal

exposure to nickel


40

3.4. East Countries

Czech Republic

The ecolabel "Ekologicky setrny vyrobek" (19, 20) is the official registered label of the Czech

ecolabelling programme (National Programme for Labelling Environmentally Friendly Products). It

was launched on 14 April 1994. At present, the Czech Ecolabel can be acquired at 41 categories of

products and two categories of services about 400 products and services bearing the label on the

market from about 100 companies. Within the several categories the most important to EPHECT are

detergents, purpose cleaners, soaps, shampoos and hair conditioners and detergents for hand

washing.

Croatia

The Environmentally Friendly Label from Croatia is based on the Blue Angel (21).

Hungary

The Hungarian Ecolabel - Környezetbarát Termék Védjegy – is based on European EcoLabel (22).

Slovak Republic

National Programme of Environmental Assessment and Ecolabelling in the Slovak Republic (NPEHOV)

is based on European EcoLabel (23).


41

Lithuania

Water Lily - national eco-labelling program created in 1996 on the basis of the European EcoLabel.

The ministry of environment of Lithuania has created environmental criteria for 15 groups of

products. Its use is rather limited because there are few such products on the market in Lithuania.

Chapter 4 Professional and Industry Standars & Practices

42

4. PROFESSIONAL AND INDUSTRY STANDARDS & PRACTICES

4.1. IFRA – International Fragrance Association

IFRA is the International Fragrance Association and is the official representative body of the fragrance

industry worldwide. IFRA was founded in 1973 in Geneva to represent the collective interests of the

fragrance industry and aims to promote the safety and benefits of the fragrance industry’s products.

To attain this objective, IFRA prepared a global Safety Program which consists of a Code of Practice;

the IFRA Standards concerning the use of several substances and more recently the IFRA Compliance

Program. The IFRA Standards form the basis for the globally accepted and recognized risk

management system for the safe use of fragrance ingredients. This is the self-regulating system of

the industry, based on risk assessments for dermal sensitization carried out by an independent

Expert Panel. Together with the industries scientific centre RIFM (Research Institute for Fragrance

Materials), the IFRA team makes sure that the establishment of usage standards for fragrance

materials is put into practice according to the available scientific recommendations and that member

companies comply with those standards. Self-regulation enables the IFRA standards to be adopted

very rapidly by fragrance houses worldwide and by the industry as a whole. IFRA Standards can be in

the form of prohibitions, concentration restrictions or purity specifications. Until the present:

- 85 Substances are prohibited, but some of them have specifications (some examples:

benzene, benzyl cyanide, ethyl acrylate, ethylene glycol monoethyl ether and its acetate,

nitrobenzene, phenyl benzoate, toluene, 2,4-undecadienal,….)

- 125 Substances are restricted – with limits expressed in contents for 11 categories of

products (some examples: benzaldehyde, benzyl alcohol, eugenol, geraniol, ….)

- 15 Substances have specifications – substances with recommendations (some examples:

limonene, linalool…)

The standards developed for the compounds judged as priorities within EPHECT are presented next.

Substances prohibited, but some of them with specifications


43

It is prohibited to use Benzene as fragrance ingredient. However it can be present in the fragrance,

but with restrictions: the level of benzene has to be kept as low as practicable and should never

exceed 1 ppm in the fragrance compound.

It is prohibited to use Toluene as fragrance ingredient. However it can be present in the fragrance,

but with restrictions: The level of toluene has to be kept as low as practicable and should never

exceed 100 ppm in the fragrance compound.

Substances restricted

The use of Geraniol as fragrance ingredient is restricted. The limits in the finished product in the

different categories are:

Category 1 0.3 % Category 7 0.9 %




Category 5 2.8 % Category 11* Not restricted

Category 6 8.6 %

* Category 11 includes all non-skin contact or incidental skin contact products. Due to the negligible skin

contact from these types of products there is no justification for a restriction of the concentration of this

fragrance ingredient in the finished product. For the purpose of complying with Standards that are not based

on the QRA, the following consumer products are considered as non-skin contact products: Solid substrate air

fresheners; Plug-in air fresheners; Membrane delivery air fresheners; Insecticides (mosquito coil, paper and

electrical); Toilet blocks; Joss sticks and candles; Plastic articles (excluding children’s toys); Fuels / Petrol and

Paint.

This Standard for Geraniol is from 2007, but a new revision is expected during 2012, so the

information presented in this report should be modified until the end of the project.

Substances with specifications

The use of Limonene as fragrance ingredient is subject to specifications:

“d-, l-and dl-Limonene and natural products containing substantial amounts of it, should only be used

when the level of peroxides is kept to the lowest practical level, for instance by adding antioxidants at

the time of production. Such products should have a peroxide value of less than 20 millimoles

peroxides per liter determined according to the FMA method, which can be downloaded from the

IFRA website (see Analytical Methods)”

The use of Linalool as fragrance ingredient is subject to specifications:


44

“Linalool and natural products known to be rich in linalool, such as bois de rose, coriander or ho wood

oil should only be used when the level of peroxides is kept to the lowest practical level. It is

recommended to add antioxidants at the time of production of the raw material. The addition of 0.1%

BHT or alphatocopherol for example has shown great efficiency. The maximum peroxide level for

products in use should be 20 mmol/l. The (hydro) peroxide content can be determined by using the

FMA method.”

To the other compounds judged as priorities within EPHECT (α-pinene, a-terpineol, formaldehyde,

acrolein, glutaraldehyde, acetaldehyde, xylenes, styrene; naphthalene, benz-a-pyrene and

phthalates) there are no IFRA standards developed.

The IFRA Analytical Working Group has developed analytical methods that allow by common

procedures the determination of the presence of potential allergens or other substances in fragrance

compounds:

- Quantitative determination of benzene and-or toluene by GC-MS

- Determination of the Peroxide Value

- Furocoumarins Guidelines

- Allergen Procedure

- Phthalates Quantification Procedure

4.2. HERA

The HERA (Human and Environmental Risk Assessment) project is a voluntary industry programme to

carry out Human and Environmental Risk Assessments on ingredients of household cleaning

products, established in 1999 between A.I.S.E. and Cefic.

The risk assessments have been conducted according to the principles of the HERA methodology (24)

to several groups and individual substances:

Esterquats; alcohol ethoxylates; linear alkylbenzene sulphonate; polycarboxylate, homo- &

copolymers; protease; sodium sulphate; amylase/lipase/cellulase; propylene glycol n-butylether;

zeolite p- and x-; diethyleneglycol n-butylether; xylene/cumene/toluene sulphonate; cocamidopropyl

betaine; isopropyl alcohol; sodium carbonate; hydrogen peroxide; citric acids / salts; secondary

alkane sulfonate (SAS); alkali silicates; boric acid; isoeugenol; hydroxycitronellal; fluorescent

brightener FWA-1; polycyclic musk AHTN; polycyclic musk HHCB; phosphonates; alcohol

ethoxysulphates; fluorescent brightener FWA-5; fatty acid salts; sodium tripolyphosphate (STPP);

zeolite A; TAED; alkyl sulphate; perboric acid, sodium salt, mono and tetrahydrate and sodium

percarbonate.

Results on the Risk Assessment performed for Human Health can be consulted for each substance in

the site http://www.heraproject.com/RiskAssessment.cfm?Status=LR.


45

4.3. Air fresheners product Stewardship programme

www.aise.eu/airfresheners

The programme is open to European companies from that industry sector, and, like most other

A.I.S.E. agreements, it goes beyond the legislative requirements covering those products. The

following pieces of legislation apply for Air Fresheners: Directive on classification, packaging and

labelling of dangerous substances - (67/548/EEC), Dangerous Preparation Directive - (1999/45/EC),

Directive on restrictions on the marketing and use of certain dangerous substances - (76/769/EEC),

General Product Safety Directive - (2001/95/EC), Aerosol Dispensers Directive - (75/324/EEC)

The programme aims at promoting best practices in the industry, through responsible

manufacturing, communication and use of Air Fresheners across Europe, allowing consumers to

make the best informed choices about safe product usage.

Companies participating in the A.I.S.E. Air Fresheners Product Stewardship Programme commit to

apply the following, specifically developed, set of rules to their products in the following areas:

Product labels

The Company shall ensure that Product labels are designed and labelled according to the following

rules:

- Good visibility to be ensured through;

- A good graphic/visual contrast between text and background;

- Key safety messages to be clearly indicated;

- Health related information in label statements;

- Where relevant and applicable, clear advice for safe usage of the product including maximum

exposure;

- Where applicable and following national requirements, inhalation abuse warnings for sprays

using solvents and propellants;

- The two following sentences shall be added to the labels:

o “People suffering from perfume sensitivity should be cautious when using this

product”

o “Air Fresheners do not replace good hygiene practices”

- The Company shall refrain from using the absence of banned materials in a product as a

marketing claim (e.g. "without CFC").

Information to be provided following Regulation 648/2004/EC on Detergents

The company shall make all information on the ingredients composition of the product from 100

ppm available - according to Regulation 648/2004/EC - to the consumers via a corporate website


46

using INCI names. The website address shall be put on the product label. In addition, an ingredient

datasheet as per annex VII C of Regulation 648/2004/EC shall be provided upon request; contact

details where to request the medical information shall also be put on the Product label.

Product shape

The Company shall not manufacture and/or put on the market toy-shape products specifically

intended to attract children. According to Directive 88/378/EEC on the safety of toys, a 'toy' shall

mean “any product or material designed or clearly intended for use in play by children of less than 14

years of age.”

Advertising

The company shall not show young children activating the Product.

The company shall not promote the Product by advertisements involving pregnant women or babies.

The company shall demonstrate appropriate use and product handling in compliance with product

labelling when advertising.

All Product claims shall be substantiated.

Additional provisions regarding Combustion Products

a) Combustion with flame

Where the Company manufactures and/or places on the market a combustion Product with flame,

i.e. perfumed candles, it shall, in addition to complying with the Dangerous Preparations Directive

1999/45/EC and all relevant legislation, adopt the latest relevant CEN standards (sooting behaviour

(EN 15426.2007), fire safety (EN 15493.2007) and product safety labels (EN15494.2007)).

b) Combustion without flame

Recent studies on air fresheners and incense point out that incense, either used in cones or sticks,

present high emissions of combustion by-products, which could be of concern due to some of the

substances which are released through combustion.

The Company shall therefore apply the precautionary principle with regards to the incense cones and

sticks which it manufactures and/or places on the market, on basis of a careful scientific risk

assessment.


47

4.4. Clean Right

It is a joint Cefic and A.I.S.E. industry website initiative providing consumers across Europe with

information and advice on the safe and sustainable use of soaps, detergents and maintenance

products. The information to consumers focuses on:

- Guidance on the importance of reading the label before using the product;

- Basic principles on how to assess the safety of ingredients used in the product;

- Safety information governing soaps, detergents and maintenance products on the market;

- Advice in case of accident or misuse;

- Information about A.I.S.E. and Cefic voluntary initiatives adopted by the industry in the areas

of safety and sustainability.

More information can be consulted on the website www.cleanright.eu.

4.5. Green Good Housekeeping Seal

The Green Good Housekeeping Seal is an emblem signifying that a product has been reviewed by the

scientists at the Good Housekeeping Research Institute, is covered by Good Housekeeping’s limited

warranty, and has met Good Housekeeping’s environmental criteria.

To evaluate a product for the Green Good Housekeeping Seal, the Good Housekeeping Research

Institute (GHRI) reviews and verifies a wide range of data related to the product's environmental

impact and the company's environmental and social responsibility performance. There are certain

criteria requirements for each product category that, if not met, will exclude a product from being

considered at the outset (see below). For most environmental and social criteria, data are scored on

a range; a product will be considered if the total score reaches a minimum of 65 points.

For the Beauty and Cleaning product categories, a product that earns the Green Good Housekeeping

Seal cannot contain certain harmful ingredients or any ozone-depleting compounds (ODCs) above

0.001%, produce volatile organic compounds (VOCs) above a certain threshold, or have been tested

on animals within the last five years (unless required by government regulation).

Specifically, the exclusions for the Beauty and Cleaning product categories are:

- Any product that has a pH of less than or equal to 2 or greater than or equal to 11.5;

- Any product that contains a substance listed as a Group 1 or 2A IARC carcinogen or under

California Proposition 65 as causing reproductive and/or developmental toxicity at a weight

of 0.001% or greater in a form that allows for a route of exposure in typical consumer use

- Any product that contains any detectable amount of any of the following compounds:


48

o Ethylene glycol monomethyl ether (CAS 109-86-4)

o Ethylene glycol monoethyl ether (CAS 110-80-5)

o Ethylene glycol monobutyl ether (CAS 111-76-2)

o Ethylene glycol monopropyl ether (CAS 2807-30-9)

o Alkylphenol ethoxylates (including nonylphenol, octylphenol, and their ethoxylates)

o Ethylene diamine tetracetic acid, ethylene dinitrilotetracetic acid, or nitrilotriacetic

acid, or the salts of these compounds

o Halogenated organic solvents

- Any product that does not meet California's Regulation for Reducing Volatile Organic

Compound Emissions from Consumer Products

- Any product that contains ozone depleting compound (ODC) ingredients at a weight of

0.001% or greater

- Any product that has been tested on animals within five years of the application submission

date (unless required by a government agency or regulation)

In addition, the detailed and lengthy Green Good Housekeeping Seal online application examines

factors that affect the product's environmental impact including:

For a maximum of 5 points in Energy Efficiency, they:

- Assess the use of energy efficient methods, including renewable energy in product manufacturing

- Check for reduction of energy use in product manufacturing facilities vs. 2006 - Review the temperature at which the final product is intended to be used (higher

temperatures require more energy)

For a maximum of 5 points in Water Reduction, they review:

- Reduction of water use in product manufacturing facilities vs. 2006

For a maximum of 15 points in Ingredient Safety and Potential Toxicity, they review:

- Comparative hazard assessment of ingredients - Lab results for LD50 oral acute toxicity - Lab results for LD50 dermal acute toxicity - Lab results for LC50 inhalation acute toxicity - Toxicity reports, per the UN Globally Harmonized System for acute aquatic organism toxicity,

skin irritation, eye irritation, skin sensitivity, and chronic target organ toxicity - pH level - Inclusion of IARC chemicals (carcinogens) - Inclusion of Prop 65 chemicals (which cause reproductive and developmental hazards) - Inclusion of EU category 1 chemicals (endocrine disruptors)

For a maximum of 15 points in Composition of Materials and Ingredients, they review:


49

- Sources of materials and ingredients - Use of certified materials and ingredients - Use of recycled content in materials and ingredients - Inclusion of genetically modified organisms in materials and ingredients - Biodegradability of product - Eutrophication potential (cleaning products only)

For a maximum of 8 points in Volatile Organic Compounds, they review:

- VOCs in the product - Compliance with VOC regulations

For a maximum of 13 points in Packaging, they review:

- Weight of packaging - Sources of packaging materials - Use of certified materials in packaging - Use of recycled content in packaging - Inclusion of genetically modified organisms in packaging materials - Biodegradability of packaging - Use of PVC in packaging - Recyclability of packaging

For a maximum of 15 points in Greenhouse Gas Emissions, they review:

- Greenhouse gas emissions from the product - Product's carbon footprint - Company's carbon footprint

For a maximum of 4 points in Waste Reduction, they review:

- Reduction of industrial and hazardous waste in product manufacturing facilities as compared to 2006

For a maximum of 2 points in Product Distribution, they determine:

- Environmentally responsible practices used in distribution of the product

For a maximum of 10 points in Corporate Responsibility, they:

- Determine if a corporate responsibility report is publicly available - Determine if a corporate responsibility report is registered with the Global Reporting

Initiative - Check for use of an Environmental Management System at product manufacturing facilities - Review any notices of violation for environmental noncompliance at product manufacturing

facilities - Review LEED or Green Globe certification of company facilities


50

- Review OSHA injury rates at product manufacturing facilities - Review use of renewable energy at nonmanufacturing company facilities - Check for SA8000 certification at product manufacturing facilities - Review percentage of company sales donated to charitable organizations

For a maximum of 5 points in Animal Testing, they:

- Review the product’s history of testing on animals

For a maximum of 3 points in Environmental Innovation, they review:

- Creative approaches to reducing the environmental impact of the manufacturing or use of the product

PART 2

51

5. FINAL REMARKS

The indoor environment in our houses is a complex system that involves many parameters which

impact on the health of the occupants. Among the various determinants which affect the quality of

the indoor air - the building materials, the furniture, the quality of the outdoor air - the activities

carried out by the occupants, including the household keeping, are also important contributors.

The exposure to air pollutants generated by the consumer products is a reality that is recognized by

all the intervenient, starting by the producers. No wonder therefore all the work of producer

associations in subjects like drafting laws, standardization groups and research projects.

This report tries to make a picture of the policies that are related with consumer products in the

frame of the EPHECT project and, more specifically, the policies which limit chemical emissions or

content of chemical contaminants in the product composition. The scope of EPHECT project are the

consumer products, known to be potential sources of hazardous and other health relevant air

pollutants in dwellings, e.g., products that emit pollutants to air and which major exposure route for

occupants to these air pollutants is inhalation.

The primary focus of this report is on European Union level policies (directives, codes, regulations

and international agreements) with impact on the utilization of some substances as ingredients of

consumer products either by the prohibition of using certain substances, or by imposing restrictions

on the used amounts: EU policies on chemicals (REACH), consumer products (GPSD), dangerous

substances (CLP/GHS) and use of biocides (BPD). More specific regulations on consumer products are

also assessed: cosmetics, detergents and toys. All these policies reveal caution regarding human

health, taking into account both type of exposures, inhalation and dermal contact.

It can be observed that the limits imposed are specified in terms of the content and never in terms of

emission, which can be explained by the absence of specific standards. Is that sufficient? For

instance, REACH, that follows a substance approach, has already limits for 58 substances. Under

Annex XVII the benzene content of consumer products is limited to 0.1% by weight, being this limit

lower for toys (0.0005%). However, a question can be asked: are these percentages low enough to

result into harmless emissions for users?

Voluntary European Actions as the European EcoLabel and Green Public Procurement (GPP) were

also referred in the report. To note that these actions have not only the human health in account,

but also the environment (water, air and waste) that, indirectly, will affect also the human health. An

important aspect to be highlighted is that the EcoLabel and GPP criteria concerning fragrances refer

to IFRA (International Fragrance Association) code, which shows the interdependence between

Industry and Public Policies. This interdependence is not necessarily negative, but particularly in this

case it should be noted that IFRA codes were based only on risk assessments for dermal sensitization.

So, more data on risk assessment should be obtained.

Chapter 5. FINAL REMARKS

52

An overview of what was and is actually been performed by the European Committee for

Standardization (CEN) in what concerns consumer products was included in the report. As CEN is a

major provider of European Standards and technical specifications, it is important to have this

information, in order to identify possible fields of intervention. In fact, as could be observed, the

number of Technical Committees dedicated to consumer products within EPHECT scope is very small.

CEN appears as a window of opportunity for the creation of Working Groups dedicated to emissions

measurements.

The report focuses after on national policies in European countries on consumer products which are

not simply the transposition of European Directives or Regulations to the national laws. The

information presented was focused on voluntary actions developed by the countries. Currently,

European Member States are obliged to transpose directives into national law, and comply with

regulations. Whenever there is a conflict between the provisions of EU law and the provisions of the

domestic (national) law of a Member State EU law will prevail.

Finally, the report focuses on voluntary actions such as industry standards, product labelling schemes

and professional good practices applied to consumer products. It can be seen that the industry is

quite active in the field of the safety of products and in communicating this message to the

consumers. However, much more might be even required if a deeper knowledge of the risk

associated with the use of consumer products is obtained.

PART 2

53

PART 2

Recommendations

PART 2

54

Chapter 1. RISK MANAGEMENT GUIDANCE FOR CONSUMER PRODUCTSroducts

55

1. RISK MANAGEMENT GUIDANCE FOR CONSUMER PRODUCTS

1.1. The consumer

Consumer products may contain toxic or potentially toxic chemical constituents to which people may

be exposed as a result of their use. Potential routes of exposure to consumer products or chemicals

released from consumer products during use include ingestion, inhalation, and dermal contact.

Inhalation route is the object of the study of the project EPHECT. Because people spend a large

amount of time indoors, the use of household chemicals in the indoor environment can be an

significant source of exposure. Very little information is available about the exact way the different

kinds of products are used by consumers, including the many ways in which these products are

handled, the frequency and duration of contact, and the measures consumers may take to minimize

exposure or risk. In addition, the factors that influence these behaviours are not well studied, but

some studies have shown that a large variation exists in behaviour between persons (Steenbekkers,

2001). However, skills and behaviour of the consumer to use the product can strongly influence the

level of risk. It is therefore essential to have a clear vision of the type of consumer who is included in

the exposure scenario. It may be necessary to generate exposure scenarios with different types of

consumers to identify the highest risk of the product. It should also be consider people who are not

actually using the product, but can be affected by the proximity of the user. Non-users, including

children, can be passively exposed to chemicals in these products. So "consumer" also could mean

people who are not actually using the product, but being possibly affected when being nearby. This is

even more obvious when talking about exposure by inhalation.

The following aspects in the definition of the consumer have to be taken into account by toxicologists

when preparing a risk assessment of a certain product, and also by the manufacturers when writing

instructions of use to consumers.

Intended/non-intended user

The usually user of a product can use the product without difficulty, because it takes all the user

instructions into account, either because he used the type of product for a long time and is therefore

familiar with its handling and use, including any apparent or not apparent hazard (s). The danger of

the product may therefore not enter into force, and the risk of product would be minor.

The non-intended user may not be familiar with the product and may not recognize the danger; it is a

consumer for whom the risk of the product is higher. Thus, the effect of a user of foreseen or

unforeseen risk may vary depending on the product and how it is used;

Vulnerable consumers

PART 2

56

Several categories of vulnerable consumers can be distinguished: Children, vulnerable people

(persons having reduced physical, sensory or mental capabilities (e.g. partially disabled, elderly

having some reduction in their physical and mental capabilities), or lack of experience and knowledge

(e.g. older children) and very vulnerable people (persons having very extensive and complex

disabilities)

They all have reduced capacities to recognise a hazard; they may also have difficulties to take

account of warning labels, or may have difficulties when using a product they have never used

before. They may also exhibit specific behaviour that affects their exposure, for example crawling

and mouthing of young children. The inhalation rates of children are also of major importance.

Because of their size, physiology, behaviour and activity level, inhalation rates of children differ from

those of adults. Infants and children have a higher resting metabolic rate and the rate of oxygen

consumption per unit body weight than adults because of their rapid growth and relatively large

surface area of the lung (SA) per unit of body weight. For example, the rate of oxygen consumption

for an infant resting between 1 week and 1 year of age is 7 milliliters per kilogram of body weight (ml

/ kg) per minute, while the rate for adults in same conditions is 3-5 ml / kg per minute (WHO, 1986).

In addition, children more often than adults, breathe through their mouths and, therefore, may have

a lesser nasal contribution to breathing during rest and while performing various activities. The

uptake of particles in the nasal airways is also less efficient in children (Bennett et al., 2008). Thus,

the deposition of particles in the lower respiratory tract may be greater in children (Foos et al.,

2008).

Therefore a product that is normally safe for an average adult may not be safe for vulnerable

consumers.

Hazard recognition and adoption of defensive behaviour

Some products are known for their risk, as pure bleach. In these cases, the danger of a product is

clearly known or easily recognisable, and the consumer can apply personal protective equipment

such as gloves, and use the product in a way that minimises the risk by opening the windows, for

example. In other cases, the danger of a product may not be as easily recognized, and the consumer

in rare cases, be able to adopt an initial risk-reducing behaviour. Manufacturers should always alert

to possible risk, even in case of low risk, when writing instructions of use to consumers.

1.2. The use of a consumer product

The EC project ENVIE (Oliveira Fernandes et al., 2008) “European co-ordination action on Indoor Air

Quality and Health Effects” (2004-2008), presented a main conclusion with relevance in this context:

the prioritization of the two main strategies for risk reduction, i.e. “source control” where the nature

or strength of the sources, or even their existence indoors is removed, replaced or moderated, and

“exposure control”, essentially through ventilation. In the ENVIE approach, the need to promote the

Chapter 1. RISK MANAGEMENT GUIDANCE FOR CONSUMER PRODUCTSroducts

57

first strategy was stressed, following the precautionary principle, according to which prevention is

better than restitution, mitigation and restoration. This option is however in the hands of the

manufacturers and policy makers that can force to decrease the contaminants present in the

consumer products. Another way considered to control exposure was the restriction of the time

spent in a particular contaminated space and, as the ultimate solution, the dilution with increased

ventilation, which can be implemented by the consumer.

Although it is not possible to attain zero risk or to obtain absolute safety in any kind of human

activity, reasonable efforts have to be made to reduce the risk from consumer products to the

minimum, according to the state of the art at the time.

First of all, in order to minimize the exposure resultant from several consumer products, the

consumer should act with responsibility and comply with the instructions of the labels of the

products. He should have conscience that some factors of their personnel activity in using a product

have consequences on the concentration he is exposed, but also his family, including children.

Manufacturer should provide this information in the instructions of use.

Frequency and duration of use

Different consumers may use a product more or less often, and for longer or shorter periods of time.

Frequency of use of a certain product, and duration of use, will have consequence on contaminant

concentration that has a direct impact on the exposure to the contaminant. The greater these factors

are, the higher the risk.

Quantity of use

The quantity of product used will have direct consequence on contaminant concentration that has a

direct impact on the exposure to the contaminant. The increase of the quantity would increase the

risk.

Use of several consumer products

It should be stressed that people can also be exposed to the same chemical from multiple sources.

Many of the sensitizing chemicals in perfumes and colognes are also found in a wide range of other

products, increasing a consumer’s total exposures and overall risk for developing allergies.

Ventilation of the space

The ventilation of a space is a fast way to dilute the concentration of a contaminant in the area

where a product was used, assuming that the outdoor air is cleaner, and will not increase the

concentration of pollutants indoors. The increase of the ventilation, by opening the windows during

PART 2

58

and after application of a product, will have direct consequence on contaminant concentration,

decreasing it, and would reduce the risk.

Ambient conditions of the space

In case of extreme conditions, as high temperatures, high levels of ozone and high levels of

particulate matter, special advices should be done to the use of certain consumer products. Those

extreme conditions could potentiate higher levels of exposure, for example to secondary pollutants

resultants from chemical reactions that normally don’t occur at normal situations.

Exposure time

After applying a cleaning product in a room, the consumer should leave the space, in order to

decrease the time exposure. If possible, children should be absent of that spaces.

Expected use

Consumers may use a product for other purposes than the product is intended for, although the use

instructions are clearly understandable including possible warnings. This aspect is particularly

important for the manufacturer of a product since he has to ensure that his product is safe under any

reasonably foreseeable conditions of use.

Chapter 2. RECOMMENDATIONS FOR POLICY MAKERS

59

2. RECOMMENDATIONS FOR POLICY MAKERS

As was already said in the previous chapter, the two main strategies for risk reduction identified by

EnVIE Project, and actually accepted, are “source control” where the nature or strength of the

sources, or even their existence indoors is removed, replaced or moderated, and “exposure control”,

essentially through ventilation. The last ones could be implemented by the consumer, for minimize

the risk, but the first one is an obligation of policy makers.

In the review of policies, it was verified that most of existing EU policies on chemicals and consumer

products (e.g. REACH, General Product Safety Directive, CLP/GHS, Biocidal Products Directive, Toys

Safety Directive, Cosmetics Directive, etc.) specify safety conditions and limits mostly based on

chemical content and not on emissions patterns.

The EPHECT’s emission testing umbrella protocol for various categories of consumer products as well

the results obtained for emission should be seen as a pre-normative work, which will provide advice

and recommendations on future standardisation of emission testing of consumer products along

with gaps identified and needs for further research. At this stage, it is no possible to propose

recommendations on limits of contaminants based on the results of the Project. But it is however

possible to propose recommendations on the strategies used to develop new guidelines.

In the last year of the project a Workshop was took place in Brussels, in May 15, in order to present

the results of the project to stakeholders, and to listen their opinions in what regards actions to be

taken. After a short discussion, a set of main conclusions could be retained as the result for the

afternoon session of the workshop.

- There is a wide array of policies in the EU and EU MS related to chemicals and consumer

products which are scattered and not fully harmonised. This, besides creating barriers in

trade, does not allow performing a robust and cumulative risk assessment of chemicals.

- More EU wide guidelines on indoor air quality is the preferred option as an umbrella of

policy, however it is difficult to reinforce them in practice especially as regards the

implementation for household products used in private dwellings. Both at EU as at MS level a

broad range of legislations and scientific studies exist which leads to confusion and delay. An

overarching long term direction is missing. Such a timeline with clear goals established at

policy level would contribute to convergence.

- The prioritisation of consumer products to focus on emission measurements and the

harmonisation of related testing methodologies are the “must-have” which subsequently

could help to develop enough good quality data to support a more robust assessment of the

risks linked to the emission of chemicals.

PART 2

60

- Some of the current policies, standards and tools related to the chemicals in consumer

products are sector-oriented, with the exception of REACH, which is useful in the

identification of substances, and should be aligned under an umbrella framework in a

comprehensive hierarchical way which will develop and enforce a minimum level of

harmonisation across the EU MS.

- Need to setup a horizontal platform for exchanging info on developments in emission testing

methodologies, results and exposure assessment for indoor air quality related policies which

amongst others will identify critical points and reinforce existing legislation on chemicals (e.g.

REACH) and consumer products, where relevant. Risk assessment approaches would take

appropriately on board these consolidated results in view of adopting restriction on chemical

content in products while in parallel accounting for their related potential emissions from the

same product(s) under typical product use in real-life scenarios.

- Product labelling could be an efficient mean of source control but a lot of work should be

done: standardized methods should exist; the methods chosen for products labelling should

be close to reality but not too complex to ease their use among the different countries,

reference materials should developed (two kinds of reference material, analytical and for

test chambers for inter-laboratory comparison exercises purposes).

- The methods for evaluate consumer products should be easy to use. Emissions should be

measured since it provides different and more representative information than content. But

face to the difficulties of measuring early emissions, the product content could be

determined at a first stage, and the emissions could be measured in case of negative

evaluation of first stage. The substances to be measured should also be well defined. Should

be the Secondary Organic Aerosol formation taken into account? Are Ultra Fine Particles,

Total Volatile Organic Compounds measured? Is a screening performed?

- The assessment of substances by ECHA would be useful for LCI generation that can be useful

for evaluation of consumer products. In some cases the evaluation could be performed

based on the content, assuming immediate release: worst case scenario.

- Testing methods should reflect the intended use and application which is not always the

case. Harmonization of scenarios for the different product groups is necessary.

- The EPHECT’s outcome should be seen as a pre-normative work, which provides advice and

recommendations on future standardisation of emission testing of consumer products along

with gaps identified. It can directly feed, inform and enrich the work undertaken by CEN

Technical Committees on consumer products and extent the recently developed CEN TC 351

horizontal standard on construction products and more importantly the recently set-up CEN

Project Committee ("PC 421") on "Emission safety of combustible air fresheners and similar

products". Harmonization would be positive for all: industry, laboratories and consumers.

- The most important obstacle identified is the need for open dialogue and communication

between the stakeholders. A continuous platform where policy makers, consumers, industry

and science exchange their needs is regarded necessary. Taking into account each other

needs leads to a win-win situation and achieves an equal partnership. This way efforts of

Chapter 2. RECOMMENDATIONS FOR POLICY MAKERS

61

industry can be validated while the policy objectives can move on and set long and midterm

targets. Creating a level playing field and achieving general protection of the citizens (not just

users) is for all parties positive.

- The existence of multiple sources in a building (building materials and consumer products)

can reveal some new issues to be explored.

It can ne seen that all participants identified the need of well defined procedures and a clear

message from policies. Some words were common to all groups: Harmonization and Simplification.

Taking in consideration all the information collected and presented before, the recommendations for

policy-makers are presented next, with different levels of action, some more general, other more

specific.

1) There is a need of more work in order to achieve European harmonised protocols for

consumer product testing - CEN as a major provider of European Standards and technical

specifications, it appears as a possible field of intervention. There is already some Technical

Committees are of interest for some of the consumer products studied under EPHECT

project, as TC 369 for Candles, TC 421 for Emission safety of combustible air fresheners and

similar products, SS H99 for “Products for household and leisure use – Undetermined” and

TC 276 for Surface active agents, with impact on Detergents and Cosmetics. However the

major part of the cleaning household products is not covered by those Technical

Committees. EC should send a clear message to all parties involved in this matter, in order to

create a Specific Technical Committee for testing emissions from household consumer

products. The new proposal on Consumer Product Safety Regulation and Market

Surveillance Regulation launched in February 2013 and currently under discussion

seems to be promising at this level, as refer actions at the level of standards and foresees the

creation of European Reference Laboratories to contribute to effective market surveillance.

2) Risk assessment is a crucial part of the process, and there is a need of improve its basis, in

order to have a realistic approach that should be convincer to producers and also to

consumers:

a. Research is needed to define more accurately the daily activity profiles of population

groups in EU, and provide subsequently more precise exposure estimates.

b. It should also be consider people who are not actually using the product, but can be

affected by the proximity of the user. Non-users, including children, can be passively

exposed to chemicals in these products. So "consumer" also could mean people who

are not actually using the product, but being possibly affected when being nearby.

c. People can also be exposed to the same chemical from multiple sources. Regulatory

bodies do not often consider the risk to human health of cumulative exposures to

the same chemical from multiple sources, nor do they consider the exposures to

multiple chemicals from multiple s sources.

PART 2

62

d. The effect of reversible sinks should be taking in account in the models: sink effects

can greatly reduce indoor air concentrations, re-emission at lower rates over longer

time periods could greatly extend the exposure period of concern.

e. The effect of extreme conditions, as high temperatures, should be considered in the

RA of certain consumer products. Those extreme conditions could potentiate higher

acute levels of exposure.

f. There is a lack on toxicological information of many volatile organic compounds, as

fragrances, on inhalation exposure. Many of the existent guidelines are based on

dermal effects.

g. There is a lack on toxicological information of the interaction of volatile organic

compounds when present in mixtures, on inhalation exposure. The additive or even

synergetic effect is unknown for many mixtures.

3) Jointly assessment – a consumer product should always be evaluated taking in account the

several routes of human exposure, and also the possible effects on the different

environment media.

4) Assurance of consumer protection, deserving special attention to disadvantaged consumers

– consumers with low level of education or low literacy levels.

Regulation is the most powerful tool to force people to create a good indoor air quality (Bluyssen,

2010). In what regards Consumer Products, at this stage there is yet a need of many research work in

order to provide secure foundations for prepare an objective regulation. However, Policy Makers

should provide the actors with the instruments necessary to increase the knowledge. It is essential to

support research and technical work, as CEN in the areas of Methods of Testing, and Risk

Assessment.

Chapter 3. RECOMMENDATIONS FOR CONSUMERS

63

3. RECOMMENDATIONS FOR CONSUMERS

“More choice and more complexity in many markets have made it increasingly difficult for

consumers to compare and assess the value of products and services,” says Michael Jenkin, Chairman

of the OECD’s Committee on Consumer Policy.

Consumer products are manufactured to serve people, with different objectives as helping to achieve

better conditions of hygiene at home, as some cleaning products, or just to improve the perfume at

home, as some air fresheners. However they should be view as a chemical product, that should be

used carefully and restrain.

Next a series of recommendations for consumers are listed, even the simplest:

1) the consumer must read the label of product which shows the characteristics of the product,

including its composition, and instructions for use. Warning about sensitizing substances and

irritant substances should deserve attention, especially if it will be used in a house with

susceptible persons (children, pregnant women, and sick people).

2) the consumer must follow the instructions for use, presented in label of product, he should

not use more than the recommended dose, and should not mix products

3) the consumer must use the product for the purpose it was intended

4) the consumer must protect his family, not exposing children or other vulnerable people, as

sick people, to chemicals compounds emitted by the consumer products. If possible, children

should be absent of the spaces where some consumer product was used..

5) after applying a cleaning product in a room, the consumer should leave the space, in order to

decrease the time exposure. All the accessories used to clean (buckets, cloths, mops,..)

should be clean with water and stored.

6) the consumer should ventilate the house in order to decrease the concentration of eventual

chemical compounds emitted by a consumer product.

PART 2

64

7) the consumer should avoid using different consumer products in the same space at the same

time, because unexpected reactions between chemical compounds emitted from different

products.

Annex – Results on Survey

65

ANNEX

Results on Survey undertaken at the Final Event at the European Parliament

On the 18th of September 2013, a final event of the EPHECT project with the objective to present the

outcomes of the project, took place at the European Parliament in Brussels. This event was hosted by

Mrs. Catherine Stihler and Mr. Claude Moraes, Members of the European Parliament (MEP).

The target participants were MEPs, researchers, EU officials, national ministries, representatives of

patients’ organisations, representatives of consumer protection organisations, industry and industry

trading organisations, and other interested stakeholders

A survey was realized at the final stage of the Meeting, to collect the opinion of the audience, using

an electronic voting system. There were six multiple choice questions to which the responses were

particularly relevant and supportive of the EPHECT objectives and irrespective follow-up. Next, the

questions and the results obtained are presented

Question 1. How would you define your professional field? (Multiple Choice)


66

Question 2. For a cleaner indoor environment we need at EU level: (Multiple Choice)

Question 3. Assuming that all standardized emission test methods are available, are you then in

favour of a labelling system (emissions) for indoor consumer products? (Multiple Choice)


67

Question 4. Do you feel a need for follow-up research or policy oriented projects, addressing

(other) consumer products, other pollutants/health effects or other indoor materials (building,

furnishing,..)? (Multiple Choice)

Question 5. Would you support (contribute to) an EU multi-stakeholder panel on IAQ and product

policies? (Multiple Choice)


68

Question 6. Do you support the following sentence: “Reduce primary emission of indoor sources

via testing (by health related evaluation schemes) and labelling – it will stimulate product

innovation and sustainability of EU products.“ (Multiple Choice)

References

69

REFERENCES

(1) Link: http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm#gpsd

(2) Link: http://ec.europa.eu/consumers/safety/rapex/index_en.htm

(3) Establishing a Comparative Inventory of Approaches and Methods Used by Enforcement

Authorities for the Assessment of the Safety of Consumer Products Covered by Directive 2001/95/EC

on General Product Safety and Identification of Best Practices. DG SANCO, European Commission.

February 2006. Link: http://ec.europa.eu/consumers/cons_safe/serv_safe/reports/risk_assesse

ment_methods_en.pdf

(4)Link: http://ec.europa.eu/enterprise/sectors/chemicals/classification/how-does-clp-

work/index_en.htm

(5) Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:123:0001: 0063:EN:PDF

(6) Link: http://ec.europa.eu/consumers/sectors/cosmetics/cosing/index_en.htm

(7) Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32009R1223:EN:NOT

(8) Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:094:0016:0021:en: PDF

(9) Commission Decision of 23 March 2005 establishing ecological criteria for the award of the

Community eco-label to all-purpose cleaners and cleaners for sanitary facilities

(10) Commission Decision of 24 June 2011 on establishing the ecological criteria for the award of the

EU Ecolabel to hand dishwashing detergents

(11) Commission Decision of 14 November 2011 amending Decisions 2006/799/EC, 2007/64/EC,

2007/506/EC, 2007/742/EC, 2009/543/EC and 2009/544/EC in order to prolong the validity of the

ecological criteria for the award of the EU Ecolabel to certain products

(12) Link: http://ec.europa.eu/environment/gpp/gpp_criteria_procedure.htm

(13) Link: http://www.cen.eu/cen/Sectors/TechnicalCommitteesWorkshops/CENTechnical

Committees/Pages/default.aspx

(14) Link: http://www.cen.eu/cen/Sectors/TechnicalCommitteesWorkshops/CENTechnical

Committees/Pages/Standards.aspx?param=6036&title=Safety of toys.

(15) M. Spruyt, M. Kuske, E. Goelen and J. Nicolas. Product Policy in the Context of the Indoor

Environment Quality. Study ordered by the EPS Health, Food Chain Safety and Environment on behalf

of the NEHAP. Contract nº 041652. Final Report. 2006.

(16) Link: http://www.ecolabels.fr/fr/la-marque-nf-environnement-qu-est-ce-que-c-est

References

70

(17) Link: http://www.nordic-ecolabel.org/criteria/product-groups/

(18) Link: http://www.blauer-engel.de/en/blauer_engel/index.php

(19) Link: http://www.ekoznacka.cz/

(20) Link: http://www.ekoznacka.cz/__C12571B20041E945.nsf/$pid/MZPMSFHMV9DV#seznam

(21) Link: http://www.mzoip.hr/default.aspx?id=8668

(22) Link: http://www.kornyezetbarat-termek.hu/

(23) Link: http://www.sazp.sk/public/index/go.php?id=1345&lang=en

(24) Link: http://www.heraproject.com/files/HERA%20TGD%20February%202005.pdf

report on existing policies, risk management guidance …

Documents