This portal is to give information to the members of IMMIB (ISTANBUL MINERAL AND METALS EXPORTERS' ASSOCIATION) about Biocidal Product Regulation.
The Biocidal Product 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. Turkey is regarded as a 3rd country (non-EU). There is no direct obligation but need to obey the rules under Regulations not to loose the market.
All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. It will repeal the Biocidal Products Directive (Directive 98/8/EC). As in the previous directive, the approval of active substances takes place at Union level and the subsequent authorisation of the biocidal products at Member State level. This authorisation can be extended to other Member States by mutual recognition. However, the new regulation also provides applicants with the possibility of a new type of authorisation at Union level (Union authorisation).
Companies can choose between several alternative processes, depending on their product and the number of countries where they wish to sell it.
National authorisation and mutual recognition:
If the product will be placed only on a single market, authorisation from that country is sufficient. If a company wishes to place the product on the market in several countries, it can apply for mutual recognition for the product authorisation.
National authorisation and mutual recognition renewal:
Renewal of a national authorisation as an application by an authorisation holder wishing to seek the renewal of a national authorisation for one or more product-types.
The Biocidal Products Regulation introduces a new alternative for companies that wish to apply for an EU-wide authorisation in one go.
There is also a simplified procedure for products which meet certain criteria specified in the regulation, e.g. do not contain any substances of concern.
Turkish Biocidal Products Regulation:
Biocidal Products Regulation with the purpose of full transposition of Turkish legislation with Acquis Communautaire and more efficient product control, has been published and came into force on December 31rd 2009 in accordance with the Directive 98/8/EC of the European Union, numbered 27449. Corrigendum to Turkish Biocidal Product Regulation is published on 12 March 2014 dated on the Official Gazette with No: 28939 and came into force on the date of publication.