The Impact of the BPR on the
Automotive Supply Chain
CLEPA MATERIALS REGULATIONS EVENT
REUTLINGEN
Melanie Jopp
Regulatory Engineer
Adam Opel GmbH
1017
May
2017 2017
May
AGENDA
1 Regulation Overview
2 Treated Articles
3 Impact on Automotive Industry
4 Automotive Industry Response (AIG-BPR)
5 Treated Articles Compliance
6 Communication in the Automotive Supply Chain
7 Automotive Enforcement Experiences
2
REGULATION OVERVIEW
• Biocidal Product Regulation (BPR)
o Regulation (EU) No 528/2012
o Came into force on 1 September 2013
o Regulation of products designed to kill, repel or inhibit undesirable organisms
by any means other than merely physical or mechanical action
o Sets rules in the EU for:
• Active Substance Approval
• Biocidal Products Authorization
• Placing treated articles on the market
o Potential compliance obligations and associated supply risk concerns
3
TREATED ARTICLES
• What is a treated article (TA)?
o Treated articles for the first time regulated with BPR from 01. September 2013
o Anything treated with a biocide, but:
• If the TA has a primary biocidal function, it’s a biocidal product.
• If the TA contains leftovers from a production process and the biocidal function was only
intended for the production process, it is out of scope.
o An article which as a whole or of which parts have been treated with a biocide
with the intention to impart a biocidal function to the article or parts of the article
• to protect the article/material from deterioration, or
• to protect humans or animals using the article from unwanted effects of harmful
organisms
4
TREATED ARTICLES
• What are the obligations for treated articles?
o When articles are treated with biocides, only for the purpose approved active
substances may be used
o Consumers have to be provided on request with the information about the
biocidal treatment of the article
o To label the product with the information on the active substance (biocidal
property of the article, instructions for use, precautionary measures, etc.)
TA labelling is required:
• if a biocidal claim is made, or
• if the approval conditions of the AS mention this as a requirement.
5
TREATED ARTICLES
• Deadline 01 March 2017
Obligation
Consequence
Relevant AS/PT is not approved on the Union List
AND the AS is not listed in Annex I
AND no application for approval is submitted by 01.09.2016
TA may not be marketed
Application for AS/PT approval done by 01.09.2016 is
rejected
TA may not be marketed
Relevant AS/PT is approved
TA may be marketed
AS is listed in Annex I
TA may be marketed
Application for approval done by 01.09.2016 is under review
TA may be marketed
6
IMPACT ON AUTOMOTIVE INDUSTRY
• Automotive Obligations
o Substances are regulated by the BPR when they are present in a product with
the intention of performing a biocidal function to the entire product.
o Complex articles (Vehicles) are also in scope, if the treated article component
still confers a biocidal benefit to the finished article.
o Biocides are contained in many parts & materials without knowing it.
o Investigation is difficult for very long supply chains.
o A dialogue with suppliers can be necessary to provide assurance of compliance.
o The supply chain has the obligation to check whether all AS are approved (or in
the approval process) for the relevant product-type.
7
IMPACT ON AUTOMOTIVE INDUSTRY
• Treated Article Examples
o
o
o
o
PT2: Vehicle with fitted air ioniser
PT7: Treated adhesive tapes
PT8: Wood/veneer inserts in interior parts (door trims), Wooden luggage decks
PT 9: Treated textile/leather for interior parts (e.g. seat covers, steering wheel covers, gear shift
knob, parking brake), Treated seat foam, Treated air filters, Anti-bacterial fleece or carrier for pets
o PT undecided: Air conditioning core, treated to reduce odour build up,
Lubricant with in-can preservative, where the AS also has a desired benefit in the use of the product
8
AUTOMOTIVE INDUSTRY RESPONSE TO THE BPR
• Automotive Task Force on Biocides
o Includes leading automotive suppliers and vehicle manufacturers:
o Cooperation with other associations (esp. Aerospace/Defence)
o BPR questions or examples → relevant trade association or to [email protected]
• Automotive Industry Guideline (AIG)
o
o
o
o
AIG-BPR version 1.0 was released in September 2016
Standardised industry approach to BPR compliance
Includes clear step-by-step compliance actions
Available at http://www.acea.be/industry-topics/tag/category/biocides
9
AUTOMOTIVE INDUSTRY RESPONSE TO THE BPR
• AIG-BPR: KEY MESSAGES
8. Maintain Records
7. Provide Information to Customers on Request
6. Label Biocidal Products and Treated Articles as Required
5. Substitute/Eliminate Active Substances where needed
4. Check Active Substances Status
3. Identify Roles and Obligations
2. Identify Product-Types
1. Identify Active Substances, Biocidal Products & Treated Articles
10
CHECK YOUR TREATED ARTICLES COMPLIANCE
• AS STATUS
o
o
o
o
Approvals for ASs and BPs granted for not more than 10 years.
AS must be approved for a specific PT.
List available on ECHA web site.
Database contains 750 active substance-product type combinations.
11
CHECK YOUR TREATED ARTICLES COMPLIANCE
• Labelling (Article 58.3)
o The obligation for labelling lies with the person or company responsible for
placing the TA on the market.
o The obligation applies at each step of the supply chain.
o A “Claim” is any statement that indicates or implies that the TA has either:
• Protection against unwanted organisms (i.e. a biocidal property); or
• Action against unwanted organisms (i.e. a biocidal function).
o Technical specifications can be a claim.
o Conditions of the approval for the contained AS require a labelling provision.
o In practice labelling information is included in the use instructions for parts or
in the vehicle manual.
12
CHECK YOUR TREATED ARTICLES COMPLIANCE
• Information on Request (Article 58.5)
o Substance name and CAS no. must be provided to consumers on request.
o The information must be provided free of charge within 45 calendar days
13
COMMUNICATION IN THE AUTOMOTIVE SUPPLY CHAIN
• IMDS
o Global tool for declaring substances that are found on the vehicle as sold
o Chemistry Manager
• GADSL
o Industry reference list for declarable (or prohibited) substances
o GADSL includes active substances relevant to vehicles (i.e. in PT7, PT8 or PT9)
o If a GADSL active substance is present, suppliers asked if it is intentionally used
as a biocide
• Other reporting tools may exist higher in the value chain
o Downstream the data will have to integrated into IMDS
14
AUTOMOTIVE EXPERIENCES – SUMMARY
• TF Biocides
o Cooperation with associations across automotive and in other industries
o Automotive Industry Guideline - Biocidal Products Regulations
• TA Compliance
o
o
o
o
o
Difficulty to identify / share biocides examples
AS that require TA labelling as a condition of their approval are difficult to identify
Product-types for some automotive products are undecided (evap core)
Ultimately suppliers are responsible to identify PTs
Late notice on free radicals generated in situ (air ionisers)
15
AUTOMOTIVE EXPERIENCES – SUMMARY
• Communication and Exchange
o
o
o
o
o
Existing supply chain substance declaration tools (IMDS/GADSL)
Chemistry Manager
Open dialog between companies involved: suppliers, distributors, manufacturers
Exchange technical knowledge of product and intended uses
If you (or your supplier) treat an article – tell your customer
• Inspections
o No specific BPR inspections reported
o REACH inspections occasionally extending to ask about biocidal active substance
approvals
16
Thank you for
your attention
www.acea.be
@acea_eu