1. The Impact of the BPR on the Automotive Supply Chain
CLEPA Materials regulations event
Reutlingen
Melanie Jopp
Regulatory Engineer
Adam Opel GmbH
17 May 2017

2. AGENDA Regulation Overview Treated Articles
Impact on Automotive Industry
Automotive Industry Response (AIG-BPR)
Treated Articles Compliance
Communication in the Automotive Supply Chain
Automotive Enforcement Experiences

3. Regulation overview Biocidal Product Regulation (BPR)
Regulation (EU) No 528/2012
Came into force on 1 September 2013
Regulation of products designed to kill, repel or inhibit undesirable organisms by any means other than merely physical or mechanical action
Sets rules in the EU for:
Active Substance Approval
Biocidal Products Authorization
Placing treated articles on the market
Potential compliance obligations and associated supply risk concerns

4. Treated articles What is a treated article (TA)?
Treated articles for the first time regulated with BPR from 01. September 2013
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.
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

5. Treated articles What are the obligations for treated articles?
When articles are treated with biocides, only for the purpose approved active substances may be used
Consumers have to be provided on request with the information about the biocidal treatment of the article
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.

6. 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
TA may not be marketed
Application for AS/PT approval done by is rejected
Relevant AS/PT is approved
TA may be marketed
AS is listed in Annex I
Application for approval done by is under review

7. IMPACT ON Automotive Industry
Automotive Obligations
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.
Complex articles (Vehicles) are also in scope, if the treated article component still confers a biocidal benefit to the finished article.
Biocides are contained in many parts & materials without knowing it.
Investigation is difficult for very long supply chains.
A dialogue with suppliers can be necessary to provide assurance of compliance.
The supply chain has the obligation to check whether all AS are approved (or in the approval process) for the relevant product-type.

8. IMPACT ON Automotive Industry
Treated Article Examples
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
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

9. Automotive Industry response to the BPR
Automotive Task Force on Biocides
Includes leading automotive suppliers and vehicle manufacturers:
Cooperation with other associations (esp. Aerospace/Defence)
BPR questions or examples → relevant trade association or to  
Automotive Industry Guideline (AIG)
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

10. 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

11. CHECK YOUR TREATED ARTICLES COMPLIANCE
AS STATUS
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.

12. CHECK YOUR TREATED ARTICLES COMPLIANCE
Labelling (Article 58.3)
The obligation for labelling lies with the person or company responsible for placing the TA on the market.
The obligation applies at each step of the supply chain.
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).
Technical specifications can be a claim.
Conditions of the approval for the contained AS require a labelling provision.
In practice labelling information is included in the use instructions for parts or in the vehicle manual.

13. CHECK YOUR TREATED ARTICLES COMPLIANCE
Information on Request (Article 58.5)
Substance name and CAS no. must be provided to consumers on request.
The information must be provided free of charge within 45 calendar days

14. Communication in the Automotive Supply Chain
IMDS
Global tool for declaring substances that are found on the vehicle as sold
Chemistry Manager
GADSL
Industry reference list for declarable (or prohibited) substances
GADSL includes active substances relevant to vehicles (i.e. in PT7, PT8 or PT9)
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
Downstream the data will have to integrated into IMDS

15. Automotive Experiences – Summary
TF Biocides
Cooperation with associations across automotive and in other industries
Automotive Industry Guideline - Biocidal Products Regulations
TA Compliance
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)

16. Automotive Experiences – Summary
Communication and Exchange
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
No specific BPR inspections reported
REACH inspections occasionally extending to ask about biocidal active substance approvals