With the latest revision of the Ordinance on Biocidal Products (OBP; SR 813.12), intellectual property protection for active substance (research) data is now also regulated in Switzerland. In accordance with the relevant provisions of the EU Biocidal Products Regulation1 (BPR), such products may only be marketed if their active substances come from listed suppliers.
1. Background and goal
In the EU, certain manufacturers and importers of active substances have participated in the ongoing work programme2 for the systematic toxicological and ecotoxicological evaluation of notified active substances and have submitted active substance dossiers. These companies have thus incurred considerable costs (for research prior to marketing). Article 95 of the BPR seeks to ensure that those not involved to date are not exempt from financial responsibilities (prevention of "free riding"), and that all parties contribute to the costs of active substance approval.
All suppliers of active substances for which dossiers have been validated are included in the ECHA list of active substances and suppliers (also known as the Article 95 List; see links listed on the right). Persons who have participated in the work programme are automatically included in the ECHA list. An additional active substance manufacturer may at any time submit a complete substance dossier or a letter of access in order to be included in the list. Manufacturers or importers of biocidal products can also have substances included in the list if the manufacturer in the supply chain fails to do so. Under the Mutual Recognition Agreement (MRA), companies domiciled or with a registered office in Switzerland do not require representation in the EU in order to be included in the Article 95 List. The first official Article 95 List was published on 24 September 2014, and updates are now issued monthly by the ECHA (see links listed on the right). This list is also used by the Swiss authorities.
2. Which biocidal products are affected?
In the EU, Art. 95 BPR is applicable from 1 September 2015 for biocidal products which, under transitional provisions, may be made available in EU countries without being authorised in accordance with the BPR (biocidal products with notified, not yet approved active substances). In Switzerland, such biocidal products may be placed on the market with the transitional authorisations AN and AC. The BPR concept of equal treatment for all persons placing active substances and biocidal products on the market is being implemented in Switzerland through annex 8 no 1.2 OBP, which covers all transitional authorisations AN and AC.
3. What action needs to be taken?
Holders of transitional authorisations AN are thus required to submit with the application the following information (according to annex 8 no. 1.2 OBP) to the Notification Authority for Chemicals (NAChem):
- evidence that the suppliers from whom the active substances contained in the biocidal product are obtained are included in the list specified in Article 95 paragraph 1 of the BPR3;
or
- if inclusion in the list has been approved by the ECHA but the entry has not yet been published: a certified copy of the ECHA decision concerning the inclusion of the suppliers from whom the active substances contained in the biocidal product are obtained;
or
- a reference to data for which the protection period specified in Article 28 OBP has expired;
Such evidence does not have to be provided for active substances contained in a biocidal product which are listed in Annex 1 OBP in categories 1-5 and 7.
For submissions as specified above, the holders of existing AN authorisations can use the PDF form available on the NAChem website to declare the origin of their active substances or to register any exemptions.
N.B.:
Within the supply chain for your biocidal product, it is sufficient if one company is included in the ECHA list for the relevant active substance and product type. Find out who, within your supply chain, is included in the ECHA list or is submitting an application for inclusion, and then submit the completed form to the Notification Authority without delay!
What should you do if your supplier is not included in the ECHA list and nobody in your supply chain intends to submit an application for inclusion?
- Apply to the ECHA for inclusion of your company in the list: for this, you must submit the documents specified in Art. 95 para. 1 BPR (letter of access to a substance dossier, or your own substance dossier).
Under the MRA, companies domiciled or with a registered office in Switzerland do not require representation in the EU in order to be included in the Article 95 List.
or
- Change the supply chain: Obtain the active substance or product from a company which is included in the ECHA List (requires an application for amendment of the authorisation)
or
- Discontinue marketing of the product: Biocidal products containing active substances from non-listed companies may no longer be placed on the market in Switzerland and must not be supplied to end consumers.
4. How can an active substance or product supplier be included in the Article 95 List?
Under the MRA, companies domiciled or with a registered office in Switzerland can submit an application directly to the ECHA for inclusion in the Article 95 List.
Information on the steps involved in applying for inclusion in the Article 95 List, as well as an overview of the ECHA authorisation process, can be found on the ECHA website (see list of links).
1] Art. 95 of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, OJ L 167 of 27 June 2012, p. 1; last amended by Regulation (EU) No 334/2014, OJ L 103 of 5 April 2014, p. 22.
2] Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council, OJ L 294 of 10 October 2014, p.1.
3] see Footnote 1
