impact of the biocidal product regulations - chemical … · impact of the biocidal product...

Impact of the BiocidalProduct Regulations

webinar, 26 March 2013, 2pm GMT

Today’s webinar – aims (1/2)To look at the different routes for authorisation and various aspects of the Regulation including the new Annex 1, the list of approved sources of biocidal products, confidentiality and data dissemination issues;

The issue of treated articles will be presented, with discussion of the definition adopted and the implications for treated articles under the BPR, including labelling and supply chain communications - and transitional requirements and deadlines;

Today’s webinar – aims (2/2)

ECHA will detail the IT tools being developed to support applications for approval of biocidal active substances and the authorisation of biocidalproducts, including IUCLID 5.5 and the registry of biocidal products R4BP 3.0, along with information on how data submitted under the existing Directive will be migrated into the new system.

Q&A session

If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar.

http://forum.chemicalwatch.com


Speakers

Jennifer Hopkins, European Regulatory Strategy and Advocacy Manager, Bayer S.A.S. Env. Science;

Dr Sara Kirkham, Senior Consultant, CEHTRA UK Ltd;

Tom Uotila, Business analyst, ECHA;

Johanna Bernsel, Legal officer, EU Commission (Q&A);

Chair: Oliver Curl, Reporter, Chemical Watch

Impact of the biocidal products Regulation: a very brief overview

Jennifer Hopkins, Bayer SAS, France

26th March 2013

• Bayer SAS • Chemwatch – 26th March 2013

Agenda The basics• Application date• New terminologyThe procedures to get a product approvedThe ‘infamous’ Article 95 -> what does it mean?Data dissemination and confidentiality

Page 2

The basics of Regulation 528/2012• Three years after the Commission published their draft of the Biocidal Products

Regulation (528/2012) the legislation was published in the Official Journal of the European Union on the 27th June 2012.• http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2012:167:SOM:EN:HTML

• The legislation entered into force in all Member States on the 17th July 2012 and will become applicable for companies on the 1st September 2013.• It entered into force in 2012 to give the European Chemicals Agency (ECHA)

time to prepare.• From the 1st September 2013 the Biocidal Products Directive will be repealed.

• The Commission claimed that ‘The new regulation on biocidal products will increase the safety of these chemical products and simplify their authorisation on the EU market, improving their free movement on the internal market.’

• The Commission also noted that ‘It will save industry an estimated 2.7 billion euros over a period of 10 years.’

• Bayer SAS • Chemwatch – 26th March 2013Page 3

http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2012:167:SOM:EN:HTML

New terminology• With new legislation comes new terminology. So “out with the old and in with the

new”.


Current legislation New legislationBiocidal Products Directive Biocidal Products Regulation BPD BPRDirective 98/8 Regulation 528/2012Annex I inclusion ApprovalInclusion in Annex IA Annex IAuthorisation AuthorisationLow risk products / registration Products eligible for the

simplified authorisation procedure

23 product types 22 product types

The requirements to get a biocidal product authorised

• Biocidal products shall not be made available on the market or used unless authorised.

• You can apply for a single biocidal product or a biocidal product family.• An authorisation shall be granted for a maximum of 10 years.• A biocidal product can be authorised if it meets the following conditions (not all

listed):• Active substance(s) are approved for the relevant product type (PT);• It is sufficiently effective;• Has no unacceptable effects;• Maximum residue limits (where appropriate) have been established;• If it contains nanomaterials the risk to the environment and human health should

be assessed separately.• IUCLID and R4BP (register for biocidal products) must be used for submissions.


The procedures to get a product approved

• Previously under the old BPD you got a product approved by applying in 1 country and then getting mutual recognition in another. Under the BPR there are a few more procedures open to you:• Union authorisation• National authorisation• Mutual recognition in sequence • Mutual recognition in parallel• Simple authorisation procedure (SAP)


Union authorisation (1)• You can apply once to ECHA for Union Authorisation and have your product approved across

the Union without the need for mutual recognition. Sounds perfect in theory, but…

• To apply for union authorisation you need to demonstrate that you have similar conditions of use across the Union.

• A document explaining what ‘similar conditions’ are agreed at the February 2013 Competent Authority meeting.

• 6 months before you make an application you must make a pre-submission.

• It only applies to certain product types and there is a phased implementation of the process:

• It doesn’t apply to those active substances that are caught by the exclusion criteria (Article 5) and those in PTs 14, 15, 17, 20 and 21.

• 1 September 2013 – those products containing one or more new active ingredients and those products in PT 1, 3, 4, 5, 18, 19.

• 1 January 2017 – PTs 2, 6 and 13

• 1 January 2020 – all remaining PTs.


Union authorisation (2)• The process according to the legislation will take a minimum of 640 days from the

day you submit your application.• Some parts of the process have no timeline in the legislation e.g. once ECHA

says the product can be authorised then the Commission has to adopt the opinion

• ECHA will not carry out the evaluation of the product – the applicant must choose a Member State first and get their agreement before applying.

• You must pay the ECHA fee (80,000€) and the national fee for evaluating a product dossier for authorisation across the Union.• Member States will not have harmonised fees but are agreeing a harmonised

fee structure.• The ECHA fee is for administrative tasks and discussions at the Biocidal

Products Committee.


National authorisation• This is the same process as what currently exists under the BPD but the timelines

for Member States are more clearly defined.• E.g. 365 days to carry out the evaluation of the product

• Cost will be related to the Member State you choose.• A lot of Member States have fees for the work under BPD but not under BPR –

will they increase their fees? Will they keep their fees at the same level?


Mutual recognition in sequence• This procedure is used when you have your product already approved in one (or

more) Member State and then you decide you want to sell in other countries e.g. national authorisation in the UK and then want to sell in Ireland.

• The process in the legislation should last 155 days from the day you submit your application.• Each concerned Member State (CMS) shall agree on the Summary of biocidal

product characteristics (SPC) and authorise after everyone agrees.• If one or more fail to agree then the rest can authorise (although discussions can

go on at the coordination group and ultimately the Commission). • Will be a fee involved: 700€ to ECHA for each mutual recognition application and

the national fees for mutual recognition in each country as well.


Mutual recognition in parallel• This is the process you use when you apply for your first authorisation in a Member

State and mutual recognition at the same time.• The whole process takes a minimum of 550 days according to the legislation.• The first authorising country and the CMSs must agree the SPC before they can

authorise the product in their country.• This is different to under BPD where the first authorising country can grant the

authorisation before the mutual recognitions are granted.• If one or more fail to agree then the rest can authorise (although discussions can

go on at the coordination group and ultimately the Commission). • Again the fees in the country will be dependent on which country you choose to be

the first country and where you seek mutual recognition. As before you will also pay 700€ to ECHA for each mutual recognition application.


Simplified authorisation procedure (SAP)

• To be eligible for this process the active substance should be included in Annex I, contain no substance of concern, no nanomaterial, be effective and does not require personal protective equipment.

• An application is made to the Agency and the evaluation by a evaluating Competent Authority takes 90 days.

• A biocidal product authorised under the SAP may be made available on the market in all Member States without the need for mutual recognition.• Authorisation holder shall notify each Member State no later than 30 days before

placing on the market.


Annex I


Category 1 –substances authorised as food additives

Category 2 –Substances included in Annex IV of REACH

Category 3 –weak acids

Category 4 _ traditionally usedsubstances of natural origin

Category 5 –Pheromones

Category 6 –substancesincluded in Annex I or IA of Directive 98/8

Category 7 -other

Lactic acid Ascorbic acid Lavender oil Oct-1-en-3-ol Carbon dioxide

Baculovirus

Sodium acetate Linseed oil Peppermint oil Webbing clothes moths pheromone

Nitrogen Bentonite

Sodium benzoate

(Z,E)-Tetradec-9,12-dienyl acetate

Citronellal

Tartaric acid Iron sulphate

Acetic acid

Propionic acid

To add a substance to Annex I• Active substances can be added to Annex I if there is evidence that they do not give rise to concern. No

timelines in the text on how long this process takes.• Rise to concern is determined as:

• Under CLP they are:• Explosive/highly flammable • Organic peroxide • Acutely toxic of category 1, 2 or 3• Corrosive of category 1A, 1B or 1C• Respiratory sensitiser• Skin sensitiser• Germ cell mutagen of category 1 or 2• Carcinogen of category 1 or 2• Human reproductive toxicant of category 1 or 2• Specific target organ toxicant by single or repeated exposure• Toxic to aquatic life category 1

• Fulfil any of the substitution criteria• Have neurotoxic or immunotoxic effects• Meets the criteria if there are equivalent concerns arising


The ‘infamous’ Article 95• From the 1st September 2013 any person wishing to place active substances on

the Union market or in biocidal products shall submit a dossier, Letter of access (LoA) or reference to a dossier (if protection periods have expired).• The Agency will publish a list of persons that have made submissions of a

dossier and includes the participants in the work programme.• If you want to get on to the list as an ‘approved source’ then you must contact

the data owners for access. For all existing active substances - mandatory data sharing shall apply to all toxicological and ecotoxicological studies including any studies not involving tests on vertebrate animals.

• As of 1st September 2015 no biocidal products on the market unless the active substance is from a ‘person’ on the published list of participants. • An additional year (September 2016) for disposal and use of products not

containing an active from the ‘approved source’ list.• All data protection periods for substance/product type combination not yet

approved shall end 31 December 2025.


Confidentiality• Data will not be disclosed if it would undermine the protection of commercial interests or the

privacy or safety of the persons concerned.• Disclosure of the following would normally be deemed to undermine protection of the

commercial interests:• Details of full composition• Tonnage• Links between active substance and person placing on the market• Names and addresses of persons involved in vertebrate animal testing.

• After authorisation has been granted access to information shall not be refused (including the following):• Name and addresses of authorisation holder, manufacturer of active and biocidal product;• Physical and chemical data;• A summary of the results of the tests required to establish the product’s efficacy and

effects on humans, animals and the environment and it’s ability to promote resistance.• A claim can be made for confidentiality with a justification that it could be harmful to

commercial interests.


Data dissemination• From the date on which an active substance is approved information such as the following

shall be made publicly and easily available free of charge:• Classification and labelling;• Result of each toxicological and ecotoxicological endpoint;• Analytical methods.

• From the date on which a biocidal product is authorised, the Agency shall make the following publicly and easily available free of charge:• Terms and conditions of authorisation• Summary of the biocidal product characteristics• Analytical methods e.g. for monitoring purposes

• From the date on which an active substance is approved or the biocidal product is authorised information such as the following shall be made publicly and easily available free of charge, except where the supplier submits and has a justification accepted:• Study summaries or robust study summaries;• The assessment report.


Conclusion• Lots of new terms to learn

• Just when you have told your marketing people the active substance is included in Annex I you have to tell them it is no longer included in Annex I.

• Different ways to get the product authorised and more timelines in the legislation• How will Member States and ECHA work to them and what will be the

enforcement if timelines aren’t met?• Lots more information on products will be made publically available so don’t forget

(if it is relevant) to apply for confidentiality claims.• The Commission has 42 implementing tasks to get the BPR working. So just

because we have BPR it is not the end.• ECHA fees, changes regulation, the same biocidal products regulation…

• There are some positives in the new text but there is also some negatives - so we will have to see if BPR is any better than its predecessor.


Thank you for your kind attention!

Treated Articles How to comply with the BPR

Sara Kirkham

Content

• What is a treated article? Definitions and examples

• Differences between treated articles and biocidal products, including decision making and implications of choice

• Labelling obligations in the supply chain• Transitional arrangements• Deadlines for compliance

2

Definitions• A treated article is any substance, mixture or

article which has been treated with, or intentionally incorporates, one or more biocidalproducts.

• A treated article that has a primary biocidalfunction shall be considered a biocidal product*.

*A biocidal product is any substance or mixture, in the form in which it is supplied tothe user, consisting of, containing or generating one or more active substances, withthe intention of destroying, deterring, rendering harmless, preventing the action of,or otherwise exerting a controlling effect on, any harmful organism by any meansother than mere physical or mechanical action

3

Examples

Biocidal product

4

Treated Article

Treated article or biocidal product?

5

Implications of choice

• Biocidal product - requires full product authorisation.

• Treated article – poses its own unique problems:⁻ Active substance approval must cover both Product

Type and use⁻ If use not covered submit an application to extend

active substance approval by 1st September 2016⁻ The conditions and restrictions specified in the

approval for use of the active substance in the biocidalproduct in the treated article must be met.

6

Labelling• Labelling of the treated article required

– If a claim is made by the manufacturer of the treated article regarding it’s biocidal properties; e. g. refrigerators with silver impregnated liners

– If there is the possibility of the active substance(s) contacting humans or being released to the environment; e.g. treated textiles such as odour reducing socks.

• Labels should include– Statement that the treated article contains a biocidal product– Substantiated biocidal property – Names of active substances and nanomaterials– Relevant instructions for use

• Label must be clearly visible, legible , durable and the in appropriate language

7

Communication obligations in the supply-chain

• Manufacturer/supplier responsible for labelling of end product Raw material or ingredient used in treated article may require labelling as a treated article. If end product contains several treated articles the label must refer to all active substances that contribute to claimed properties or for which conditions apply.

• Supplier of treated article, e.g. shop, wholesaler, distributor must respond to customer requests within 45 days, free of charge.

• Downstream user or customer has the right to information on the biocidal treatment of the treated article.

8

Transitional Arrangements• Existing treated article: Available on the EU market on 1st

September 2013• So-called Market Freeze for new treated articles after 1st

September 2013• Existing treated articles can stay on the market until 1st

Sept 2016• Existing articles containing an existing active substance for

which a non-inclusion decision on the relevant PT is made must be removed from the market 180 days after the decision or on 1st Sept 2016, whichever is the later.

• New treated articles containing new active substances can only be placed on the market after active substance approval.

9

Deadlines• Labelling of treated articles

1st September 2013• Application for new PT/Use for active substance

1st September 2016• Application for a biocidal product previously out

of scope of 98/8/EC1st September 2017

10

[email protected]

CEHTRA UK Ltd 6th Floor, City Gate East, Toll House Hill, Nottingham NG1 5FS UK

11

http://www.cehtra.com

mailto:[email protected]

IT Tools for BPRA brief on IUCLID & R4BP

26.03.2013

Tom Uotila

3/26/2013 2

Contents

• Introduction• New IT tools

• IUCLID 5.5• R4BP 3.0• The ”big” picture

• Data migration• In conclusion

Introduction

3/26/2013 3

IUCLID 5.5International Uniform Chemical Information Database

• Store and manage scientific/technical data• Active substances - Annex II

data requirements• Biocidal products - Annex III

data requirements

• Creation of “dossiers” submitted to the authorities under the processes of the BPR

3/26/2013

R4BP 3.0Registry for Biocidal Products

• Store and manage administrative data related to the BPR processes• Submission of applications

• Submission and management of the Summary of Product Characteristics (SPC)

• Workflow support for the handling of applications

• Registry of product authorisations and other BPR related decisions made by the authorities

3/26/2013 5

BPR processes

3/26/2013 6

Active substance• Approval of active substance (Article 7, 8, 9, 10)• Renewal of active substance (Article 13, 14)• Review of active substance (Article 15)• Active substance evaluation under Directive 98/8/EC (Article 90)• Amendment of Annex I (Article 28) • Access to active substance dossiers (Article 95)• Assessment of technical equivalence (Article 54)• Inquire to share data (Article 61, 62)

National authorisation• National authorisation (Article 29, 30)• Mutual recognition in parallel (Article 34, 37)• Mutual recognition in sequence (Article 33, 37)• National authorisation - simplified procedure (Article 25, 26)• Notification for placing on the market (Article 27)• Renewal of national authorisation (Article 31)• Cancellation or amendment of national authorisation (Article 47, 48)• National authorisation cancellation on request (Article 49, 50)• National authorisation administrative change (Article 49, 50)• National authorisation minor change (Article 49, 50)• National authorisation major change (Article 49, 50)• Notification of product in product family (Article 17(6))• Notification of unexpected or adverse effect (Article 47)• Notification of experiment or test (Article 56)• Parallel trade (Article 53)• National authorisation of the same biocidal product (Article 17 (7))

Union authorisation• Union authorisation (Article 43, 44)• Renewal of Union authorisation (Article 45, 46)• Cancellation or amendment of Union authorisation (Article 48)• Union authorisation cancellation on request (Article 49, 50)• Union authorisation administrative change (Article 49, 50)• Union authorisation minor change (Article 49, 50)• Union authorisation major change (Article 49, 50)• Notification of product in product family (Article 17(6))• Notification of unexpected or adverse effect (Article 47)• Union authorisation of the same biocidal product (Article 17 (7))

Centrally hosted biocides IT tools

R4BP

The “big picture”

3/26/2013

7

Industry Authority

IUCLIDAuthority

IUCLID

Company

IUCLID

Company

Inte

rnet

Dossier AS/BP

Dossier AS/BP

Dataset AS/BP

IUCLID

MSCA

IUCLID

Commission

IUCLID

ECHA

Sec

ure

ECH

A /

RSA

Dossier Dossier AS/BP

AS = Active substanceBP = Biocidal product

Data migration

• Migration of data from R4BP2 (legacy system) to R4BP3 (new system)

• All complete product authorisations obtained under Biocidal Products Directive (Dir 98/8/EC) are foreseen to be migrated

• Before migrating product authorisations it is important that ownership of the authorisations is established correctly• As a solution, companies will be asked to complete a company sign-up procedure

with ECHA to obtain a legal entity unique identifier and mark their authorisations in R4BP2 with this identifier

3/26/2013 8

In conclusion

Key IT implications of implementing BPR

1. Move from a largely paper based system to an electronic submission of the technical dossiers

2. Workflows to support the implementation of the BPR procedures/processes

3. Electronic dissemination of information on active substances and biocidal products by ECHA

3/26/2013 9

Q&A session

If you have any unanswered questions please submit them to the Chemical Watch Forum, after the webinar.



Thank you for attending

A downloadable recording of this presentation (with slides) will be available shortly. If you have any questions, please contact Lorna ([email protected])

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