From 1 September 2015, a biocidal product cannot be supplied for distribution or use in the EEA unless the active substance supplier or biocidal product supplier is on the Article 95 List in the relevant product type. This list is on the ECHA website, which was last updated on 8 May 2015. It is a similar principle to Article 5 of REACH (“no data, no market”).
This raises compliance, and also supply chain issues which are considered in this article.
What is Article 95 BPR designed to achieve?
Its purpose is to ensure that the costs of obtaining data required for approval of an active substance/support it through the EU Review Programme are shared fairly. Some companies are included automatically on the Article 95 List, i.e. if they have submitted a dossier for approval of an active substance/are supporting an active substance through the EU Review Programme. Others (manufacturers /importers of active substances or biocidal products) will be added to the Article 95 List if they submit their own dossier, a letter of access to an existing dossier (having paid relevant costs), or if data protection periods for an existing dossier have expired a dossier reference.
Article 95 requirements apply even if an active substance is in the EU Review Programme. They are in addition to general BPR requirements, and affect all active substances/biocidal products in the EEA, irrespective of the country in which they are placed on the market.
What does this mean in practical terms?
If you are manufacturing or importing an active substance or biocidal product in the EEA or importing into the EEA, you should be on the Article 95 List for the relevant product type. Applications are made by creating an IUCLID dossier and submitting it through ECHA’s Register for Biocidal Products, R4BP 3. An application must be accompanied by the relevant fee. (There are specific provisions regarding re-imports into the EEA of an active substance or biocidal product manufactured in the EEA which should be considered if relevant).
If your supplier is based in the EEA, you do not need to be on the Article 95 List so long as someone in your supply chain is listed for the active substance or biocidal product for the relevant product type.
In all cases, you need evidence to demonstrate compliance, since EEA regulators expect to see an audit trail.
You can expect questions related to Article 95 from your customers and to be asked for evidence regarding compliance.
What evidence is required?
The approach of regulators may vary across different EEA Member States. This is because the BPR, like REACH, is enforced at national level, even though it is directly effective in all EEA Member States.
In the UK, the Health and Safety Executive expects evidence (“a clear auditable trail”) to demonstrate compliance with Article 95 to be provided to enforcement authorities on request.
There is some flexibility as to what this evidence should comprise. This can include written confirmation of the source of the active substance and a link to the source’s entry on ECHA’s Article 95 List. Equally, contractual documentation showing supply of the substance from an Article 95 listed company would suffice.
What are the consequences of breach of Article 95?
The commercial consequence is that the biocidal product in question can no longer be supplied after 1 September 2015. In addition, penalties can be imposed for breach. There may be differences in enforcement policy and penalties in different EEA Member States.
- Do you need to be on the Article 95 list?
- Are your supplies from an Article 95 listed company?
- Do you confirm this regularly to ensure that the supply chain has not changed/the relevant company remains listed?
- Do you have the evidence you need to demonstrate compliance?
- Do your contractual arrangements with suppliers/customers cover this?