The Impact of the BPR on the Automotive Supply Chain

Transcription

1 The Impact of the BPR on the Automotive Supply Chain CLEPA MATERIALS REGULATIONS EVENT STUTTGART Dr. Melanie Jopp Regulatory Engineer Opel Automobile GmbH 19 April May 2017

2 AGENDA 1. Impact on the Automotive Industry 2. Treated Articles in the Automotive Industry 3. Automotive Industry Response (AIG-BPR) 4. Communication in the Automotive Supply Chain 5. Automotive Enforcement Experiences 6. Conclusion 1

3 REGULATION OVERVIEW TA = Treated Article AS = Active Substance BP = Biocidal Product PT = Product-Type 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 2

4 IMPACT ON THE AUTOMOTIVE INDUSTRY TA = Treated Article AS = Active Substance BP = Biocidal Product PT = Product-Type 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 Usually the supply chain (and not the OEM) has the obligation to check whether all AS are approved (or in the approval process) for the relevant product-type. o A dialogue with suppliers can be necessary to provide assurance of compliance. 3

5 TREATED ARTICLES IN THE AUTOMOTIVE INDUSTRY TA = Treated Article AS = Active Substance BP = Biocidal Product PT = Product-Type What is NOT a Treated Article (TA)? o Anything treated with a biocide, but: if the product has a primary biocidal function, it s a biocidal product (BP). if the product contains leftovers from a production process and the biocidal function was only intended for the production process. if the product was treated with a BP, but there is no biocide remaining in/on the product. What is a Treated Article (TA)? 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, e.g. to protect the article/material from deterioration, or to protect humans or animals from unwanted effects of harmful organisms. 4

6 TREATED ARTICLES IN THE AUTOMOTIVE INDUSTRY TA = Treated Article AS = Active Substance BP = Biocidal Product PT = Product-Type What are the obligations for Treated Articles (TA)? o Check for your TAs, if all contained ASs are approved for the relevant PT or are in the review process (= Check Union List) or are included in Annex I. Approval needs not to be done for each individual supplier. It is sufficient if the AS has been approved for a PT once by any company. o Ensure that the TA is labelled with the information of the AS (biocidal property of the article, instructions for use, precautionary measures, etc.), if a biocidal claim is made, or the approval conditions of the AS mention this as a requirement. o Provide to a consumer, on request, information on the biocidal treatment of the TA within 45 days, free of charge. 5

7 TREATED ARTICLES IN THE AUTOMOTIVE INDUSTRY TA = Treated Article AS = Active Substance BP = Biocidal Product PT = Product-Type Timeline for Treated Articles Case 1: AS is already approved (Listed on the Union List) or Annex I Placing TA on the market without limitation (max for 10 years) Case 2: No application made Stop Placing TA on the market until new application has been approved Case 3: Application made (= Review Program) Placing TA on the market until decision is made Positive Negative Placing TA on the market Without limitation (max for 10 years) TA may not be placed on the market from 180 days after the non-approval decision Latest Application Date If the AS in the TA is approved then the TA can be placed on the EU market. If the AS in the TA is not approved OR if the application for approval is not submitted by then the TA must not be placed on the EU market. 6

8 TREATED ARTICLES IN THE AUTOMOTIVE INDUSTRY TA = Treated Article AS = Active Substance BP = Biocidal Product PT = Product-Type Examples of Automotive Treated Articles o PT7: Treated adhesive tapes o PT8: Wood/veneer inserts in interior parts (door trims); Wooden luggage decks o PT9: 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 odor build up; Lubricant with in-can preservative, where the AS also has a desired benefit in the use of the product 7

9 TREATED ARTICLES IN THE AUTOMOTIVE INDUSTRY TA = Treated Article AS = Active Substance BP = Biocidal Product PT = Product-Type Principle of Logic o A TA is always having a desired biocidal property. o Such desired property usually is known to the customer/oem In most cases it is even required by the OEM (e.g. prevention of bad odor) o If the customer/oem doesn t know about the biocidal function: You don t have to investigate completely up into the supply chain in order to find out if a biocide has been used to treat an article. If treatment took place, but customer is not aware of it, then it can be usually assume that there is no desired biocidal function and thus no TA. I don t know the biocidal property of the TA It is not a desired biocidal function It is not a TA I don t have any obligation 8

10 AUTOMOTIVE INDUSTRY RESPONSE TO THE BPR Automotive Task Force on Biocides (TF Biocides) o Includes leading automotive suppliers and vehicle manufacturers: o BPR questions or examples relevant trade association or to bpr@acea.be Automotive Industry Guideline (AIG) o AIG-BPR version 1.0 was released in September 2016 o Standardised industry approach to BPR compliance o Includes clear step-by-step compliance actions o Available at 9

11 AUTOMOTIVE INDUSTRY RESPONSE TO THE BPR AIG-BPR V2.0 o Small changes for clearer understanding o Tense changes for past dates o Table removed, replaced by Flow Chart 1.1 o Annexes split from main document: Annex A: Automotive BP, TA and Claim Examples As always, please provide any new examples to the TF-Biocides Annex B: Relationship of the BPR to Other Regulations Unchanged, but will require significant update for Brexit Annex C: Template letters for Consumer Notification Unchanged Annex D: Active Substances Requiring TA Labelling New (see next slide) 10

12 AUTOMOTIVE INDUSTRY RESPONSE TO THE BPR Annex D: Active Substances Requiring TA Labelling o TA labelling is required if: a biocidal claim is made, or the approval conditions of the AS mention this as a requirement. o For recent AS approvals it is becoming increasingly common to include the TA labelling requirement as a condition o Annex D lists these substances in automotive-relevant PTs and gives links to the relevant legal text 11

13 AUTOMOTIVE INDUSTRY RESPONSE TO THE BPR Publicity/Support for Automotive Industry Approach to BPR o Chemical Watch articles o Webinar planned, featuring automotive approach 12

14 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 PT2, 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 13

15 VEHICLE AIR IONISERS Vehicle Air Ionisers current status under the BPR o If the air ioniser is intended to have a biocidal actions, suppliers of the ioniser unit are responsible for: Active substance approval (application before Sept 2016) AS for ionisers = in situ generated active substance(s) Biocidal product authorisation (application before AS approval decision) BP for ionisers = in situ generated active substance(s) and any other generated substances Product notification (if BP approval was for product family) Record-keeping o There are no BPR obligations for: Biocidal product labelling - not applicable for in situ generated substances Treated article labelling Neither the air ioniser device itself, nor the vehicle fitted with the device, are treated articles But check and follow any conditions of the active substance approval, when granted 14

16 VEHICLE AIR IONISERS Vehicle Air Ionisers status under US FIFRA o Applicable if air ioniser is placed on US market and pesticidal claim is made. o Vehicle manufacturer (or importer) is responsible for: Registration of the production establishment (whether US or non-us) Initial Reporting; Notice of Arrival; Annual Reporting; Record-keeping Correct labelling & appropriate advertising claims Vehicle Air Ionisers status under California ARB o Applicable for ALL vehicle air ionisers does not rely on biocidal intention o Ioniser device supplier is responsible for: Air cleaning device testing; Notification; Certification; Record-keeping Device Marking; Packaging Labelling 15

17 AUTOMOTIVE ENFORCEMENT EXPERIENCES TA = Treated Article AS = Active Substance BP = Biocidal Product PT = Product-Type TA Compliance o Difficulty to identify / share biocides examples o AS that require TA labelling as a condition of their approval are difficult to identify o Product-types for some automotive products are undecided (e.g. evap core) o Ultimately suppliers are responsible to identify PTs Communication and Exchange o Existing supply chain substance declaration tools (IMDS/GADSL) o Chemistry Manager o Open dialog between companies involved: suppliers, distributors, manufacturers o Exchange technical knowledge of product and intended uses o If you (or your supplier) treat an article tell your customer 16

18 SUMMARY TA = Treated Article AS = Active Substance BP = Biocidal Product PT = Product-Type Conclusion o The automotive industry is usually not placing AS or BPs on the EU market, but only TAs. o The obligations, if we place a TA on the EU market are not very difficult to fulfill. o Furthermore, IMDS provides an investigation method (Chemistry manager) to check for biocides intentionally used in our vehicles. o A dialogue with suppliers can be necessary to provide assurance of compliance. Communication in the supply chain is needed. o The number of TAs is most likely very limited (evap. core, leather seat, ) o Only very few cases (if any) where such a TA is containing an AS that is not either on the Union List or in the review program or in Annex I. o No specific BPR inspections reported until now. 17

19 Thank you for your attention