Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – REACH Registration, Only Representative, REACH Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance Services.
We offer preparation of all documents required for registration of a biocidal product and place on the market:
- Biocidal product entry in the Register
- Material Safety Data Sheet (MSDS)
- Text part of the label
- Instructions for use, if not stated on the label
The Biocidal Products Regulation
(BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the biocidal product.
The Regulation becomes applicable on 1st September 2013. From that date onwards, companies will have two options to request permission to place their products on the market. The first (Union Authorisation), which is likely to be used by large firms, requires companies to submit an application to ECHA and if the product is judged safe, it may be sold throughout the EU. The second may appeal more to the numerous small and medium-sized enterprises in this business, as it requires companies to submit an application to their own national authority, to sell a product in their home country. If the authorisation is granted, they can subsequently put the product on the market of other Member States, according to the mutual recognition principle.
Union authorisation allow companies to place these biocidal products on the market in the entire Union, without the need to obtain a national authorisation followed by mutual recognition. This authorisation will give the same rights and obligations in all the Members States as those issued by the national authorisation. Union authorisation will be granted to biocidal products with similar conditions of use across the Union, except those containing active substances meeting the exclusion criteria and certain product-types (14, 15, 17, 20 and 21). Depending upon the product types, Union authorisation will be available in three different stages:
- from 1 September 2013 for product types 1, 3, 4, 5, 18 and 19
- from 1 January 2017 for product types 2, 6 and 13
- from 1 January 2020 onwards to the remaining products types 7, 8, 9, 10, 11, 12, 16 and 22.
The authorisation process starts with the submission of a dossier by a company to ECHA. The evaluating competent authority that has previously been chosen by the applicant, evaluates the dossier and forwards the result to ECHA’s Biocidal Products Committee to prepare an opinion within 180 days. Finally, the European Commission takes a decision based upon ECHA’s opinion.
Approval of active substances: companies have to apply for the approval of an active substance by submitting a dossier to ECHA. After the validation check has been performed by the Agency, the evaluating competent authority carries out a completeness check and an evaluation. The result is forwarded to ECHA’s Biocidal Products Committee, which prepares an opinion within 270 days. This is then submitted to the European Commission for decision-making. A similar process takes place for the renewal of the approval of an active substance.
The European Commission keeps a register of Biocidal Products on “R4BP” which is published on the website https://webgate.ec.europa.eu/env/r4bp/user.login.cfm. It is recommended to make the first part of his application prestredníctvo that register and indicate both your potential interest in the product on the basis of mutual recognition in other EU Member States. Sign in R4BP is possible only through an account created in the system, ECAS (European Commission’s authentication service). Issues related to R4BP application if necessary, consult directly with the administrator ENV-R4BP_BIOCIDAL-REGISTER@ec.europa.eu
Ecotoxicological center offers preparation of all documentation you need for placing on the market of biocidal product:
- Form for announcement of biocidal product containing only notified active substances,
- MSDS in Slovak language fully compliant with Annex II, Article 31 of Regulation (EC) No. 1907/2006 (REACH),
- Product label (has to be in Slovak language),
- Instructions for use (has to be in Slovak language),
In cooperation with GLP laboratories we offer also laboratory services for testing of active substance in biocidal products.
- EU legislation:
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
Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market
Commission Regulation (EC) No 1896/2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products
Commission Regulation (EC) No 1687/2002 on an additional period for notification of certain active substances already on the market for biocidal use as established in Article 4(1) of Regulation (EC) No 1896/2000,
Commission Regulation (EC) No 2032/2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation (EC) No 1896/2000
Commission Regulation (EC) No 1451/2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market
An exhaustive list of 23 product types:
Disinfectants and general biocidal products
Product-type 1: Human hygiene biocidal products
Product-type 2: Private area and public health area disinfectants and other biocidal products
Product-type 3: Veterinary hygiene biocidal products
Product-type 4: Food and feed area disinfectants
Product-type 5: Drinking water disinfectants
Product-type 6: In-can preservatives
Product-type 7: Film preservatives
Product-type 8: Wood preservatives
Product-type 9: Fibre, leather, rubber and polymerised materials preservatives
Product-type 10: Masonry preservatives
Product-type 11: Preservatives for liquid-cooling and processing systems
Product-type 12: Slimicides
Product-type 13: Metalworking-fluid preservatives
Product-type 14: Rodenticides
Product-type 15: Avicides
Product-type 16: Molluscicides
Product-type 17: Piscicides
Product-type 18: Insecticides, acaricides and products to control other arthropods
Product-type 19: Repellents and attractants
Other biocidal products
Product-type 20: Preservatives for food or feedstocks
Product-type 21: Antifouling products
Product-type 22: Embalming and taxidermist fluids
Product-type 23: Control of other vertebrates
Within the framework of cooperation with certified laboratories we offer laboratory services and, if necessary, the testing of the active substance contained in biocidal products.
If you have questions please contact us by phone +421 2 45943712, or e-mail to ekotox(at)ekotox.sk