The Impact of the BPR on the Automotive Supply Chain

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Presentation transcript:

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

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

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

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

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.

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 Relevant AS/PT is approved TA may be marketed AS is listed in Annex I Application for approval done by 01.09.2016 is under review

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.

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

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 bpr@acea.be   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 http://www.acea.be/industry-topics/tag/category/biocides

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

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.

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.

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

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

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)

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