Workshop on European Food Contact Legislation - Aspects of Plastics Packaging

AGR 48764

Zagreb,26 November – 27 November 2012

Monica Maria COJANU, Superior Councilor for National Sanitary Veterinary and Food Safety Authority, Romania

Summary

Printing, labeling, traceability EU legislation

Evaluation of toxicological concerns and risk assessment procedure

Specific migration of heavy metals from plastic packaging/restriction for only 7 metals from Regulation 10/2011/EC

Printing, labeling, traceability Reg. (EC) No. 1935/2004

General requirements for all FCM Do not endanger human health Do not change composition of the food in unacceptable

way Do not mislead the consumer Be manufactured according to good manufacturing

practice Traceability Labelling

Reg. (EC) No. 1935/2004Art. 15 - Labeling

Materials and articles, which are not yet in contact with food when placed on the market, shall be accompanied by:

the words ‘for food contact’, or a specific indication as to their use, such as coffee machine, wine bottle, soup spoon, or the glass-and-fork symbol;

The provisions as has been stated above are not be obligatory for any articles which, because of their characteristics, are clearly intended to come into contact with food ( e.g. spoon, fork, wine glass etc.)

special instructions to be observed for safe and appropriate use;

the name or trade name and, in either case, the address or registered office of the manufacturer, processor, or seller responsible for placing on the market established within the Community;

Regulation (EC) No. 1935/2004Art. 15 - Labeling

adequate labeling or identification to ensure traceability of the material or article;

other relevant information such as the name and quantity of the substances released by the active component so as to enable FBOs who use these materials and articles to comply with any other relevant Community provisions or,

the national provisions applicable to food, including the provisions of food labelling.

Reg. (EC) No. 1935/2004Art. 15 - Labelling

The information regarding labelling must be clearly legible and indelible.

Retail trade in materials and articles shall be prohibited if the information required under art. 15 of Reg. 1935/2004 is not given in a language easily understood by purchasers.

The Member State in which the material or article is marketed may stipulate that those labelling particulars shall be given in one or more languages which it shall determine from among the official languages of the Community.

Regulation (EC) No. 1935/2004Art. 15 - Labelling

At the retail stage, the information required under art. 15 shall be displayed on:

the materials and articles or on their packaging; or labels affixed to the materials and articles or to their packaging; or if, for technical reasons, that information or a label bearing it cannot

be affixed to the materials and articles at either the manufacturing or the marketing stage, a notice in the immediate vicinity of the materials and articles and clearly visible to purchasers;

At the marketing stages other than the retail stage, the information shall be displayed on:

the accompanying documents; or the labels or packaging; or the materials and articles themselves.

Labelling requirements

An article or material intended for food contact must be labelled or bear the wine glass and fork symbol.

This labelling is not obligatory if the characteristics of articles are clearly intended to come into contact with food e.g. knife, fork, wine glass.

Labelling, advertising and presentation of food contact materials must not mislead consumers.

Information on the appropriate use of food contact materials or articles must be provided, if necessary

Are traceable throughout the production chain.

Polyethylene Terephthalate (PET or PETE): .

High Density Polyethylene (HDPE):

Vinyl (Polyvinyl Chloride or PVC)

Low Density Polyethylene (LDPE)

Polypropylene (PP)

Polystyrene (PS)

Other

PLASTIC LABELLING PLASTIC LABELLING (Society of Plastic Industry)(Society of Plastic Industry)

Polyethylene (PE) : LDPE – HDPE- Uses: Bags for bread, vegetables, chicken, ham or meat for fridge and freezer, containers (squeezable) for salt and sauces, bowls for food storage. Milk, water and juice containers, retail bags, yogurt and margarine tubs, cereal box liners

• Polycarbonate esters (plasticizers e.g. Bisphenol -A) – Uses: Infant feeding bottles, plates, mugs, jugs, beakers, microwave oven ware and storage containers

Polypropylene (PP) Uses: Containers and lids for hot food

& drinks. Packaging of snacks, biscuits, crisps etc. Ketchup bottles, yogurt containers and margarine tubs.

Polyvinylchloride (PVC)Uses : Packaging of alcoholic drinks

e.g. beer, wine and also fatty foods. Trays for products such as chocolate bars and cookies. Films for wrapping meat, vegetables and fruits. Jars for coffee and chocolate drinks.

Polystyrene (PS) Uses: Cups in vending coffee machines, trays for meats, vegetables and fruits in supermarkets. Also, containers for dairy products such as yoghurt and cheese, ice-cream, syrups and honey. Packaging/trays for meat, fish and vegetables. Trays for cake and margarine tubes when is used as copolymer with acrylonitrile, butadiene.

Polyethylene Terephthalate (PET or PETE )

Uses: Plastic soft drink and water bottles, beer bottles, mouthwash bottles, peanut butter and salad dressing containers, food trays and boil-in-the-bag packs.

Traceability Definition

The following meanings of the traceability definition according with EU legislation:

Article 2 of Reg. (EC) No. 1935/2004 ‘traceability’- the ability to trace and follow a material or

article through all stages of manufacture, processing and distribution;

Article 18 of Regulation (EC) No. 178/2002 ”traceability ” - means the to track any food, feed, food-

producing animal or substance that will be used for consumption, through all stages of production, processing and distribution

Reg. (EC )1935/2004 Art. 17

Traceability The traceability of materials and articles shall be

ensured at all stages in order to facilitate: - Control- the recall of defective products - consumer

information and the attribution of responsibility;

The business operators (BOs) - have in place systems and procedures to allow the following:

- identification from to which materials are supplied - identification of substances or products and its

implementing measures used in their manufacture That information made available to the competent

authorities on demand;

Traceability requirements

The materials and articles, which are placed on the market in the Community, shall be identifiable by an appropriate system, which allows

their traceability by means of labelling or relevant declaration of compliance and documentation

or information.

Traceability in the area of plastic food contact materials and articles is very complex.

FBO-s responsibilities

The responsible food business operators should:a) be able to identify from whom and to whom a product has been

suppliedb) have systems and procedures in place that allow for this information

to be made available to the competent Authorities upon their request.

The requirement relies on the “one step back-one step forward” approach which implies for food business operators that:

a) They shall have in place a system enabling them to identify the immediate supplier (s) and immediate customer (s) of their products

b) A link “supplier-product” shall be established (which products supplied from which suppliers)

c) A link “customer-product” shall be established (which products supplied to which customers)

Traceability information

The BO-s should provide the following information from production of raw materials to supplier:

the lot number of raw materials used in the production the date in which each single step of the production had

been carried out plant and manufacturing line identification other information related to Quality Control

RECALL

In the case of a problem occur at the retail stage the following steps would be:

the retailer identifies his supplier the supplier determines whether if the defect is from his

internal process or a defective raw material. the supplier contacts his own raw material supplier, and

they can contact their suppliers, and so on. each affected stakeholder contacts his customer(s) with

information on which products are potentially defective. each customer takes appropriate measures such as a

recall or other corrective actions.

Printing inks

Inks and varnishes have been a prime source of food safety incidents.

The use of printing inks has to comply with the general rules of Regulation (EC) No 1935/2004 and with good manufacturing practice as laid down in Commission Regulation (EC) No 2023/2006.

There is not yet any specific European legislation concerning printing inks - No EU Limits!

Guidelines - Regulation 2023/2006/EC (GMP) and

Choice of starting materials, not : toxic, mutagenic, carcinogenic

Photo-initiators of UV applications found in inks, adhesives, coatings (i.e. benzophenone, 4-methylbenzophenone, ITX-2-isopropyl thioxanthone).

Reg. EC 1935/2004 Art. 3 – General rules

The substances from the printed layer on the outside of food packaging could contaminate food, even without direct contact;

This contamination is known as migration - is a diffusion - controlled process, transport of molecules (known as migrants) from an area of higher concentration to one of lower concentration;

Only substances from ,,positive lists’’ should be used in printing inks and have to comply with the specific migration limit (SML).

Specific migration limitDefinition

The SML is the maximum permitted amount of a given substance that can be released from a material (packaging material and/or printed layer) into food.

Non-evaluated substances for which no data is available should not be detectable.

A generally accepted definition of ‘detectable’ is ‘below 10 ppm``

Reg. (EC) No 2023/2006(GMP)

Application to the non-food contact side of a material or article that substances from the printed surface are not transferred to the food-contact side:

(a) through the substrate or

(b) by set-off in the stack or the reel,in concentrations that lead to levels of the substance in the food which are not in line with the requirements of Article 3 of Regulation (EC) No 1935/2004.

Same applies to handling and storage of finished and semi-finished products.

The printed surfaces shall not come into direct contact with food!

RASFF Notification

In 2009 the German authorities reported through RASFF that 4 - methyl benzophenone had been detected in breakfast cereal produced in Belgium and packaged in a polyethylene bag inside a printed carton board outer package

The contamination – migration of 4- methyl benzophenone from the printed surface of the cardboard box where it is used as photo-initiator

The European Printing Ink Association (EuPIA) has provided risk assessments performed on their request.

There is a specific migration limit (SML) for benzophenone of 0.6 mg/kg for its use as an additive in plastics

The EFSA evaluates the risk of the presence in of 4 -methylbenzophenone found in cereals based on the limited exposure data available of a similar substance, benzophenone.

EFSA concludes that short term consumption of contaminated breakfast cereals should not pose a risk to the consumer

EU risk assessment

EU agencies task on risk assessment: EFSA - promote and coordinate the development of uniform risk

assessment methodologies - art. 23 (b) of Regulation (EC) No 178/2002;

EFSA Panel - Food contact materials, enzymes, flavourings and processing aids (CEF)

- deals with questions on the safety of use of FCM - evaluate the safety of use of the substances in the

context of authorisation procedures Other EU institution – Joint Research Center (JRC) There is a collaboration agreement between Joint Research

Center (JRC) and EFSA National agencies - each MS should either carry out its own risk

assessment for ensure that the EFSA risk assessment (in particular exposure) is applicable for its own population

Risk Assessment ProcessToxicologists, exposure experts, chemists etc

Toxicological data

Exposure data

Risk characterisation

Standard setting

- Acceptable or Tolerable Daily Intakes (ADIs,TDIs)

- Reference doses (e.g. Acute Reference Dose, ARfD)

- Legal process - Specific/Overall Migration Limits (SMLs ( Acceptable (Tolerable) Daily Intake (a person weighing 60kg eats 1kg of food packed in plastics containing

the substance in the maximum permitted quantity

Acute Reference Dose - the amount of substance in food, expressed on a body weight basis, that can be

ingested over a short period of time, usually during one day, without appreciable risk to the consumer )

Role of EFSAReg. (EC) No 1935/2004

Art. 10 of Reg. (EC) No. 1935/2004 EFSA - carry out risk assessments on the risks originating from the

migration of substances from FCM into food EFSA - deliver a scientific opinion on new substances intended to

be used in food contact materials before their authorisation and inclusion in a positive list or for substances which are already authorised but need to be re-evaluated.

Art. 8 and 9 of the Reg. (EC) No. 1935/2004 – procedures the industry submits applications to the Member States Authorities transmit the applications to the EFSA for their evaluation. the application is supported by a technical dossier submitted by the

industry following the SCF guidelines for the “presentation of an application for safety assessment of a substance to be used in food contact

Risk Analysis Framework EFSA opinion is published – Risk assessment (science based)

Meeting of European Commission and Member States to review the opinion and prepare legal measure – e.g. Overall Migration Limit and Specific Migration Limit (SML) - Risk management (policy based)

Communication of outcome - Risk communication (interactive exchange of information and opinions concerns risk)

EFSA Procedures European Commission or MS required EFSA evaluates

substances intended for use in materials in contact with food

Terms of Reference, time to deliver an answer

EFSA Panel (Food contact materials, enzymes, flavourings and processing aids (CEF) - considers the relevant information (toxicological, exposure)- carry out risk assessment

Assesses the risk (scientific meetings) and develops an “Opinion” on the safety of substances used or intended to be used to manufacture materials which come into contact with food.

RASFF The Rapid Alert System for Food and Feed (RASFF) - tool to

exchange information about measures taken responding to serious risks detected in relation to food or feed.

Type of risks on FCM notified throughout RASFF: use of unauthorised substances in food contact materials and

migration of the substance; food contact materials that bring about unacceptable changes in

the composition or organoleptic properties (taste, aroma, appearance, colour) of the food;

misleading labelling, advertising or presentation of a food contact material.

Romanian Risk assessment procedures

National Sanitary Veterinary and Food Safety Authority (NSVFSA)

co-ordinating body for entire food chain

risk assessment on the entire food chain

National Contact Point (NCP) on RAS, MANCP, Country Profile

Ministry of Health (MH) is responsible for:

legislation in relation to food contact materials

checks the compliance of food contact materials according

with EU and national legislation on FCM

RASFF notification on FCM

Scientific Council with 4 expert working groups on risk assessment has been established

The Scientific Council Organization

Components of SC: Members of SC – chemists,

toxicologists, veterinarians, human doctor, academician and profesor from different universities (University of Agriculture, Faculty of Veterinary, University of Medicine and Pharmacy, other universities)

President of SC Vice-president Consultants Secretary

4 Scientific Committee (Panel) with minimum 3 members/panel

Committee on aditives, flavouring, food contact materials and substances used in feeding

Committee on GMO, nutrition, toxicology, alergens and hygiene public health

Committee on biological risks and contaminants

Committee on identification, registration, animal health and welfare

The Scientific Council Task

The Scientific Council meets quarterly or as often as necessary for the examination and discussion of issues related veterinary and food

safety at the request of NSVFSA Each Committee of SC submit to NSVFSA a scientific report

Scientific Council task: to provide risk assessment in the sanitary veterinary and food

safety area to provide scientific opinions related sanitary veterinary and food

safety area to propose measures for risk management according with food

safety legislation (FCM, pesticides residues, food and feed aditives, GMO)

to promote scientific methods on risk assessment to propose methodology and guides on risk assessment

Specific migration of heavy metals from plastic packaging/restriction for only 7 metals from Regulation 10/2011/EC on plastic materials and articles intended to come into contact with food

Reg. (EC) no. 10/2011/EC Migration limits

Specific Migration Limits (SML) are expressed in mg of substance per kg of food (mg/kg). They are fixed on the basis of a toxicological evaluation- Acceptable Daily Intake (ADI) or the Tolerable Daily Intake (TDI)

Those specific migration limits (SML) - every day throughout lifetime, a person weighing 60kg eats 1kg of food packed in plastics containing the substance in the maximum permitted quantity.

For substances for which no specific migration limit or other restrictions are provided in Annex I, a generic specific migration limit of 60 mg/kg shall apply.

Reg. (EC) no. 10/2011/ECGeneral requirements

Art. 8 - General requirements on substances used in manufacture FCM

the composition shall be known to the manufacturer of the substance and made available to the competent authorities on request.

Art. 9 - Specific requirements on substances the specific migration limit the overall migration limit the restrictions and specifications set out in column 10 of

Table 1 of point 1 of Annex I; the detailed specifications set out in point 4 of Annex I.Art.10 - General restrictions related to plastic materials and

articles are laid down in Annex II.

Reg. (EC) no. 10/2011/EC

Art. 11 - Specific migration limits plastic materials and articles shall not transfer their constituents to

foods in quantities exceeding the (SML) set out in Annex I; for substances for which no SML or other restrictions are provided in

Annex I, a generic specific migration limit of 60 mg/kg shall apply. additives which their use is authorised as food additive or flavouring

substances shall not migrate into foods in quantities having a technical effect in the final foods and shall not exceed the restrictions provided in Reg. (EC) No 1333/2008 or in Reg. (EC) No 1334/2008;

Art. 12 - Overall migration limit Plastic materials and articles shall not transfer their constituents to

food simulants in quantities exceeding 10 milligrams of total constituents released per dm 2 of food contact surface (mg/dm 2 ).

Reg. (EU) no. 10/2011 Annex II

(Restricted Substances)

Plastic materials and articles shall not release the following heavy metals in quantities exceeding the specific migration limits :

Barium = 1 mg/kg food or food simulant. Cobalt = 0,05 mg/kg food or food simulant. Copper = 5 mg/kg food or food simulant. Iron = 48 mg/kg food or food simulant. Lithium = 0,6 mg/kg food or food simulant. Manganese = 0,6 mg/kg food or food simulant. Zinc = 25 mg/kg food or food simulant.

EFSA Scientific Report on the risk assessment of salts of authorised acids,

phenols or alcohols for use in FCM

EC request to EFSA to carry out risk assessment of authorised acids, phenols and alcohols as well as these of the cations lithium, copper, barium, cobalt and manganese

If the risk assessment of authorised acids, phenols and alcohols cover also their salts for use in food contact materials or there is a need for specific evaluation of the salts themselves.

The overall conclusion is that risk assessments of the acids, phenols and alcohols and of the cations lithium, copper, barium, cobalt and manganese can also be used for their salts.

Reg. (EC) no. 10/2011/EC Art.6

The following substances that are not included in the Union list are authorised subject to the rules set out in Articles 8, 9, 10, 11 and 12 of Reg. (EC) 10/2011:

a) salts (including double salts and acid salts) of aluminium, ammonium, barium, calcium, cobalt, copper, iron, lithium, magnesium, manganese, potassium, sodium, and zinc of authorised acids, phenols or alcohols

EFSA Scientific Opinion cobalt stearate as oxidation catalyst in PET

The EFSA received an application from France to evaluate the risk of the migration of substance (1,4-butanediol, cyclized, polymers with glycidyl methacrylate, hydroxyl-terminated polybutadiene, methyl methacrylate and styrene) copolymer in PET and the use of cobalt stearate as oxidation catalyst in PET.

The migration and compositional tests were performed on PET bottles the Stearic acid is authorised as additive for plastic materials and

articles in contact with food the cobalt salts of authorised acids are also authorised with a

specific restriction limit (SML) of 0.05 mg/kg food, expressed as cobalt (Reg. EU no. 10/2011)

Regarding cobalt stearate, used as an oxidation catalyst, the CEF Panel noted that some cobalt salts (but not cobalt stearate) are included in the (ECHA) Candidate List of substances of Very High Concern for authorisation, classified for carcinogenicity

EFSA Conclusion: ,,The use of cobalt stearate as oxidation catalyst in PET, is not of

safety concern for the consumer.

EFSA Scientific opinion substance iron (II) modified bentonite

EFSA received an application from Spain, the evaluation of the substance iron (II) modified bentonite.

The active substance is intended to be incorporated in plastic layers in contact with type of food under conditions of long term of storage at room and may also be used in sachets placed in the headspace of the primary packaging of solid foodstuffs, not in direct contact with the food.

The EFSA - carry out a risk assessment on the risks originating from the migration into food of the substance iron (II) modified bentonite, and deliver a scientific opinion, according to the Reg. (EC) No 1935/2004.

Iron powder (FCM Substance No 983) is authorized as additive for plastic materials and articles in contact with foods (Reg. (EU) No 10/2011) with a specific restriction of 48 mg iron/kg

Conclusions of the CEF Panel

The EFSA concluded that : 1) the substance iron (II) modified bentonite does not

raise a safety concern for the consumer 2) the substance equally does not raise a safety concern

when it is used in sachets, placed in the headspace of the packaging, that prevent the physical release of their contents into the food and are not in direct contact with liquid foods, exudates……

FCM database

Contains information on substances authorized or not yet authorized;

The authorized use of active substances shown the following information:

individual restriction (SML) or ND migration restrictions and specifications ( other than SML) ex: for

use certain polymers, use of biocide authorized is covered by authorization of another

substance

Analysis of migrated substances

The specific migration is analysed in the food using an analytical method in accordance with the requirements of Article 11 of Regulation (EC) No 882/2004.

Ensure that CA designates laboratories that may carry out the analysis of samples taken during official controls and that all designated laboratories are accredited in accordance with EN ISO/IEC 17025 as required by Article 12 of Regulation (EC) No 882/2004.

Consider the scope of analytical tests on FCM (Article 24(1) of Regulation (EC) No 1935/2004 and Article 3(3) of Regulation (EC) No 882/2004).

More information on Food Contact Materials

http://ihcp.jrc.ec.europa.eu/our_activities/food-cons-prod/food_contact_materials,

http://ec.europa.eu/food/food/chemicalsafety/foodcontact/documents_en.htm,

http://www.efsa.europa.eu/en/panels/fip.htm,

THANK YOU FOR YOUR ATENTION!