During their meeting in May 2015, the Member State biocidal competent authorities (''CA'') discussed and finalised two important documents related to the issue of implementation and enforcement of Article 95 of the Biocidal Products Regulation (EU) 528/2012 (''BPR''). Both of them touch upon the question of how multinational companies within the same corporate group should be listed on the Article 95 list. However, the consensus reached between the European Commission and the CAs, is not clear and leaves one crucial question open – i.e. what really amounts to a supply chain link for compliance with Article 95 BPR?
According to the first document (CA-May15-Doc.4.13-Final "Compliance with and enforcement of Article 95"), authorities could ask companies to provide a self-declaration (indicating how they comply with Article 95). In terms of evidence to be provided, the document states that it is suggested that a simple letter could be used as proof of supply. This letter should be issued by either the substance or product supplier included on the Article 95 list and should confirm that either the company included on the Article 95 list, or one of its affiliates or distributors, is the substance or product supplier. This would imply that it would be sufficient for a multinational company to have one entity (e.g. mother company) on the list.
The second document (CA-May15-Doc4.13-Annex-Final "Templates for self-declaration form and letter of confirmation of supply") states that that any documentary evidence linking the company as part of the supply chain to a supplier on the list could also be provided,instead of a letter from a supplier on the list.
As noted, none of these documents provide an explanation or specify the type of link which is necessary to prove affiliation between companies within one corporate group for compliance with Article 95 BPR. One can assume that it is not always required to demonstrate a legal link with the entity on the list or that it holds the shares of the other company. Therefore, it seems that the assessment will be carried out by the national authorities on a case-by-case basis (which might also depend on the national legislation).
The European Chemicals Agency (''ECHA'') Guidance on Article 95 is also silent on the question of the type of link. It merely states the following in section 126.96.36.199:
''If a company is included in the Article 95 list, its daughter companies and affiliates are not automatically listed or explicitly covered by this listing. However, the link between the products and the company on the list can be demonstrated by documentary evidence proving the traceability. Therefore, to comply with the provisions of Article 95 it would be sufficient that one company is listed if the daughter companies or affiliates are part of the supply chain linking the product to the company on the list.''
This approach seems to be stricter than the one provided in the CA documents, since it specifically refers to an affiliate being part of the same supply chain.
This lack of a clear vision may lead to a problem for multinational companies which import into the European Economic Area (''EEA'') through different affiliates, or for companies who have different manufacturing sites in the EEA. In these cases, it can be understood that each importing and each manufacturing entity may need to be included on the Article 95 list, because they occupy different supply chains.
The verb "may" is used because we should bear in mind the following scenarios:
- Article 95(1) BPR (as amended by Regulation 334/2014) does no longer make it mandatory to be included on the Article 95 list –– it is now voluntary (use of the word "may"). This means, for example, that a manufacturer/importer can still sell (place on the market) an active substance without being included on the Article 95 list (if he/she sells it as a commodity chemical, there would also not be a pre-marketing authorisation requirement as a biocide).
- Compliance with Article 95 BPR must be assessed at the biocidal product level (see Article 95(2) BPR); therefore, in the situation of the first bullet, the biocidal product formulator buying the active from the manufacturer/importer concerned will need to be listed. If the formulator is listed, all its downstream users (customers, distributors or private label companies) will be in compliance.
- ECHA takes the position that as long as one entity in the same supply chain is included in the Article 95 list, the requirement is met. Theoretically, therefore, this should apply down and up the chain (however, it is hard to find examples where it could apply up the chain).
- A special case is toll manufacturing: a toll manufacturer is not a manufacturer (substance supplier) for Article 95 BPR purposes, because it does not place a substance on the market under his own name/trademark –– the toll manufacturer's client will be the manufacturer (substance supplier) for Article 95 BPR purposes.
If you would like to discuss any of these issues please contact us.
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