“- any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,
- any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action
A treated article that has a primary biocidal function shall be considered a biocidal product”
Biocides of Veterinary Use Products are biocides to be applied in animals, their premises and surroundings or in any activity related to it, in food and feed area as well as drinking water for animals.
Law: - 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 (BPR) incorporates all of the amendments and corrigenda to the BPR adopted to date. - Decreto-Lei n.º 140/2017 de 10 de novembro which ensures implementation and ensures compliance, in the internal legal order, with the obligations arising from Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012
The EU Biocides Regulation (Regulation 528/2012) covers a very diverse group of products, including disinfectants, pest control products and preservatives. It repeals and updates the Biocidal Products Directive 98/8/EEC from 1 September 2013. Products are organized in four main groups containing 22 different product types. The four main groups are: - disinfectants, for home and industrial use - preservatives, for manufactured and natural products - pest control products - other specialist biocidal products, e.g. antifouling products A full list of product types can be found in Annex V of the Biocidal Products Regulation.
On national level, there are two Competent Authorities (CA): • Directorate General for Food and Veterinary (Direção-Geral de Alimentação e Veterinária - DGAV) – CA for Biocides of Veterinary Use Products and Wood preservatives. • General Directorate of Health (Direção –Geral de Saúde DGS) – CA for all the biocides not mentioned on the above description.
General Directorate of Health is also the National Coordination Authority.
For more informations please consult ECHA website.
Transitional period During the transitional period, the following rules apply: - Article 89.º of the BPR - Article 19.º of Decreto-Lei n.º 140/2017 de 10 de novembro; - Despacho n.°4/G/2018, that sets the transitional rules for Biocides of Veterinary Use Products.
1. Application for Biocides of Veterinary Use Products authorization
All the Biocides of Veterinary Use Products that are not exclusively PT4 need and authorization prior to placing in the market
BPR Rules – After the transitional period The decision to approve an active substance is published by the EU Commission approximately 24 months before the formal approval date. Approval dates can be found in the Implementing Regulation published for that active substance. See ECHA Active Substance database. All companies making Biocides of Veterinary Use Products available on the Portuguese market should keep themselves up to date with the status of the active substance in their product(s) through the biocides review programme. The deadline for applications for authorisation of Biocides of Veterinary Use Products under EU BPR (as amended) is the date of approval of the last active substance in that product. If no application for product authorisation is made under EU BPR (as amended), the 365 day phase out period as set out in Article 89 of EU BPR (as amended) will apply from the date of approval of the last active substance in the product. The 365 day phase out period for the product is made up of: - 180 days for making the product available; and - 365 days for its use. Note: The 180 day period for making the product available on the market relates to all making available of the biocidal products from the top of the supply chain (e.g. manufacturer or formulator) down to when the user receives it (e.g. from a distributor or retail store/website). Companies wishing to place Biocides of Veterinary Use Products on Protuguese market can apply for product authorisation at National or Union level under the following application types. The European Chemicals Agency (ECHA) has published the following guidance documents to support the EU Biocides Regulation 528/2012. Guidance on information requirements - This Guidance deals with the information requirements on active substances and on biocidal products. Applicants should use this document when preparing dossiers for product authorisation. Biocides Submission Manual (BSM) - The aim of the Biocides Submission Manual (BSM) series is to provide industry users with detailed and illustrative technical assistance. The BSM series describes how to build IUCLID dossiers for the various Biocidal Product Regulation applications and how to submit and manage those applications in R4BP 3 until a successful outcome is achieved. Guidance and training on IUCLID is also available. For application of Biocides of Veterinary Use Products on Protuguese market the following document must be uploaded in R4BP3: Application form.
Enquiries regarding applications for Biocides of Veterinary Use Products under the transional period