Regulation (EU) No. 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.

Subject

Environment gen., Cultivated plants

Keyword

Pollution control Hazardous substances Pesticides Precautionary principle Cultural heritage Cleaning agents/detergents Disinfection/disinfestation Plant protection Internal trade Packaging/labelling Authorization/permit

Geographical area

European Union Countries

Abstract

This Regulation lays down harmonized rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment. The provisions of this Regulation are underpinned by the precautionary principle, the aim of which is to safeguard the health of humans, the health of animals and the environment. These rules concern in particular: (a) the establishment at European Union level of a list of active substances which may be used in biocidal products; (b) the authorization of biocidal products; (c) the mutual recognition of authorizations within the Union; (d) the making available on the market and the use of biocidal products within one or more Member States or the European Union; and (e) the placing on the market of treated articles.

Full text

English

Website

europa.eu

References - Legislation

Repeals

Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market.

Legislation | European Union | 1998

Keyword: Disinfection/disinfestation, Packaging/labelling, Internal trade, Authorization/permit, Animal health

Source: FAO, FAOLEX

Commission Directive 2013/44/EU amending Directive 98/8/EC of the European Parliament and of the Council to include powdered corn cob as an active substance in Annexes I and IA thereto.

Legislation | European Union | 2013

Keyword: Plant protection, Pesticides, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Implemented by

Order No. 1290 on Pesticides.

Legislation | Denmark | 2015

Keyword: Biological control agents, Classification/declassification, Hazardous substances, Pesticides, Use restrictions, Authorization/permit, Packaging/labelling, Pollution control

Source: FAO, FAOLEX

Order No. 1232 on Pesticides.

Legislation | Denmark | 2015

Keyword: Biological control agents, Classification/declassification, Hazardous substances, Pesticides, Public land, Use restrictions, Authorization/permit, Packaging/labelling, Pollution control

Source: FAO, FAOLEX

Act No. XXV of 2000 on chemical safety.

Legislation | Hungary | 2000 (2013)

Keyword: Hazardous substances, Pollution control, Classification/declassification, Registration, Access-to-information, Packaging/labelling, Transport/storage, Data collection/reporting

Source: FAO, FAOLEX

Regulation No. 548 on Biocides (Biocide Regulation).

Legislation | Norway | 2014

Keyword: Hazardous substances, Data collection/reporting, Internal trade

Source: FAO, FAOLEX

European Union (Biocidal Products) Regulations 2013 (S.I. No. 427 of 2013).

Legislation | Ireland | 2013

Keyword: Plant protection, Pesticides, Inspection, Packaging/labelling, Internal trade, Authorization/permit, Data collection/reporting, Registration, Enforcement/compliance, Offences/penalties

Source: FAO, FAOLEX

Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013 (S.I. No. 1506 of 2013).

Legislation | United Kingdom | 2013

Keyword: Pesticides, Institution, PIC-prior informed consent, Pollution control, Hazardous substances, International trade, Authorization/permit

Source: FAO, FAOLEX

Decree No. 224 of 2008 (IX. 9.) of the Government concerning detailed rules of application of the chemical load penalty.

Legislation | Hungary | 2008 (2013)

Keyword: Offences/penalties, Polluter pays principle, Pollution control

Source: FAO, FAOLEX

Biocidal Products (Fees and Charges) Regulations (Northern Ireland) 2013 (S.R. No. 207 of 2013).

Legislation | United Kingdom | 2013

Keyword: Biosecurity, Pesticides, Royalties/fees

Source: FAO, FAOLEX

Biocidal Products (Fees and Charges) Regulations 2013 (S.I. No. 1507 of 2013).

Legislation | United Kingdom | 2013

Keyword: Biosecurity, Pesticides, Royalties/fees

Source: FAO, FAOLEX

Decree No. 128 of 2009 (X. 6.) FVM of the Ministry of Agriculture and Rural Development concerning veterinary medicinal products.

Legislation | Hungary | 2009 (2014)

Keyword: Animal health, Authorization/permit, Drugs, Internal trade, Animal feed/feedstuffs, International trade, Legal proceedings/administrative proceedings, Offences/penalties, Registration, Inspection, Data collection/reporting

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) No. 1032/2013 approving bromoacetic acid as an existing active substance for use in biocidal products for product- type 4.

Legislation | European Union | 2013

Keyword: Plant protection, Pesticides, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) No. 1034/2013 approving aluminium phosphide releasing phosphine as an active substance for use in biocidal products for product type 20.

Legislation | European Union | 2013

Keyword: Plant protection, Pesticides, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) No. 1035/2013 approving benzoic acid as an existing active substance for use in biocidal products for product- types 3 and 4.

Legislation | European Union | 2013

Keyword: Pesticides, Plant protection, Authorization/permit, Internal trade

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) No. 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No. 528/2012 of the European Parliament and of the Council.

Legislation | European Union | 2013

Keyword: Plant protection, Pesticides, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Biocidal Products (Implementation of Regulation (EU) No. 528/2012) Regulations, 2013 (L.N. 348 of 2013).

Legislation | Malta | 2013

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Law implementing the Regulation (EU) no. 528/2012 of the European Parliament and Council concerning the making available on the market and use of biocidal products.

Legislation | Croatia | 2013

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit, Institution

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) No. 88/2014 specifying a procedure for the amendment of Annex I to Regulation (EU) No. 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.

Legislation | European Union | 2014

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Regulation (2013:63) on pesticide fees.

Legislation | Sweden | 2013

Keyword: Royalties/fees, Pesticides, Inspection, Plant protection, Authorization/permit, Agricultural development, Internal trade, Hazardous substances

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) No. 354/2013 on changes of biocidal products authorised in accordance with Regulation (EU) No. 528/2012 of the European Parliament and of the Council.

Legislation | European Union | 2013

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Chemicals Act (9.8.2013/599).

Legislation | Finland | 2013

Keyword: Pollution control, Environmental standards, Public health, Hazardous substances, Hazardous waste, Monitoring, Standards, Protection of environment, Transport/storage, Enforcement/compliance, Legal proceedings/administrative proceedings, Radiation, Waste management

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) No. 438/2014 approving cyproconazole as an existing active substance for use in biocidal products for product-type 8.

Legislation | European Union | 2014

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) No. 437/2014 approving 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as an existing active substance for use in biocidal products for product-type 21.

Legislation | European Union | 2014

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Decision 2014/227/EU on the non-approval of certain biocidal active substances pursuant to Regulation (EU) No. 528/2012 of the European Parliament and of the Council.

Legislation | European Union | 2014

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) No. 90/2014 approving decanoic acid as an existing active substance for use in biocidal products for product- types 4, 18 and 19.

Legislation | European Union | 2014

Keyword: Pesticides, Authorization/permit, MRL-maximum residue limit, Food quality control/food safety, Animal feed/feedstuffs, Standards

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) No. 91/2014 approving S-methoprene as an existing active substance for use in biocidal products for product- type 18.

Legislation | European Union | 2014

Keyword: Pesticides, Standards, Authorization/permit

Source: FAO, FAOLEX

Ordinance repealing Ordinance establishing the list of active substances satisfactory for inclusion in biocidal products and the list of active substances with low risk satisfactory for inclusion in biocidal products of low risk.

Legislation | Slovakia | 2013

Keyword: Plant protection, Pesticides, Internal trade, Packaging/labelling

Source: FAO, FAOLEX

Commission Implementing Decision (EU) 2015/646 pursuant to Article 3(3) of Regulation (EU) No. 528/2012 of the European Parliament and of the Council on bacterial cultures intended to reduce organic solids and to be placed on the market for that purpose.

Legislation | European Union | 2015

Keyword: Plant protection, Internal trade

Source: FAO, FAOLEX

Decree No. 316 of 2013 (VIII.28.) of the Government on certain rules concerning the authorization and the placing on the market of biocidal products.

Legislation | Hungary | 2013 (2013)

Keyword: Access-to-information, Authorization/permit, Hazardous substances, Inspection, Pollution control, Pesticides, Plant protection

Source: FAO, FAOLEX

Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013 (S.I. No. 206 of 2013).

Legislation | United Kingdom | 2013

Keyword: Pesticides, Institution, Pollution control, Hazardous substances, International trade, Authorization/permit

Source: FAO, FAOLEX

Biocidal Products (Fees and Charges) Regulations (Northern Ireland) 2015 (S.R. No. 254 of 2015).

Legislation | United Kingdom | 2015

Keyword: Biosecurity, Pesticides, Royalties/fees

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2015/406 approving Bacillus thuringiensis subsp. israelensis serotype H14, strain SA3A as an active substance for use in biocidal products for product-type 18.

Legislation | European Union | 2015

Keyword: Pollution control, Hazardous substances, Pesticides, Plant protection, Internal trade, Packaging/labelling

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2015/407 approving propan-2-ol as an active substance for use in biocidal products for product-types 1, 2 and 4.

Legislation | European Union | 2015

Keyword: Pollution control, Hazardous substances, Pesticides, Plant protection, Internal trade, Packaging/labelling

Source: FAO, FAOLEX

Comssion Implementing Regulation (EU) 2015/405 approving alpha-cypermethrin as an active substance for use in biocidal products for product- type 18.

Legislation | European Union | 2015

Keyword: Pollution control, Hazardous substances, Pesticides, Plant protection, Internal trade, Packaging/labelling

Source: FAO, FAOLEX

Commission Delegated Regulation (EU) No. 1062/2014 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.

Legislation | European Union | 2014

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2015/1730 approving hydrogen peroxide as an existing active substance for use in biocidal products for product-types 1, 2, 3, 4, 5 and 6.

Legislation | European Union | 2015

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2015/1731 approving medetomidine as an active substance for use in biocidal products for product-type 21.

Legislation | European Union | 2015

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2015/1727 approving 5-Chloro-2-(4-chlorophenoxy)phenol as an existing active substance for use in biocidal products for product-types 1, 2 and 4.

Legislation | European Union | 2015

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2015/1728 approving IPBC as an existing active substance for use in biocidal products for product-type 13.

Legislation | European Union | 2015

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2015/1729 approving potassium sorbate as an existing active substance for use in biocidal products for product-type 8.

Legislation | European Union | 2015

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2015/1726 approving 2-methylisothiazol-3(2H)-one as an existing active substance for use in biocidal products for product-type 13.

Legislation | European Union | 2015

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Federal Act for implementing the Biocidal Products Regulation (Biocidal Products Act).

Legislation | Austria | 2013 (2020)

Keyword: Pollution control, Hazardous substances, Pesticides, Classification/declassification, Inspection, Packaging/labelling, Registration, Authorization/permit, Royalties/fees, Monitoring, Sustainable use, Offences/penalties, Hazards, Internal trade, Public health

Source: FAO, FAOLEX

Biocidal Products (Implementation of Regulation (EU) No. 528/2012) (Amendment) Regulations, 2015.

Legislation | Malta | 2016

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Authorization/permit

Source: FAO, FAOLEX

Law on Biocidal Products Act 2014 (No. 34(I)/2014).

Legislation | Cyprus | 2014

Keyword: Pollution control, Hazardous substances, Pesticides, Classification/declassification, Inspection, Internal trade, Registration, Authorization/permit, Monitoring, Offences/penalties, Precautionary principle, Packaging/labelling, Plant protection

Source: FAO, FAOLEX

Commission Implementing Decision (EU) 2016/1943 pursuant to Article 3(3) of Regulation (EU) No. 528/2012 of the European Parliament and of the Council on the use of paraffin oil for coating eggs to control the population size of nesting birds.

Legislation | European Union | 2016

Keyword: Pollution control, Hazardous substances, Precautionary principle

Source: FAO, FAOLEX

Act on biocide products.

Legislation | Poland | 2015

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Delegated Regulation (EU) 2017/2100 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No. 528/2012 of the European Parliament and Council.

Legislation | European Union | 2017

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Biocidal Products Act (2009)

Legislation | Estonia | 2009 (2016)

Keyword: Pollution control, Hazardous substances, Pesticides, Governance, Public health, Environmental standards, Business/industry/corporations, Packaging/labelling, Authorization/permit, Inspection, Liability/compensation, Internal trade, International trade, Standards, Protection of environment

Source: FAO, FAOLEX

Cabinet Regulation No. 628 of 2013 on Requirements in Relation to Activities with Biocidal Products

Legislation | Latvia | 2013

Keyword: Pollution control, Hazardous substances, Pesticides

Source: FAO, FAOLEX

Order No. 82 of the National Sanitary Veterinary and Food Safety Authority validating the Methodological Rules for the application of the provisions of the Government Decision no. 617/2014 on establishing the institutional framework and measures for the implementation of Regulation (EU) no. 528/2012 of the European Parliament and of the Council of 22 May 2012 on the making available on the market and use of biocidal products.

Legislation | Romania | 2017

Keyword: Hazardous substances, Pesticides, Packaging/labelling, Enforcement/compliance

Source: FAO, FAOLEX

Governmental Decision No. 617 on the establishment of the institutional framework and measures for the implementation of Regulation (EU) no. 528/2012 of the European Parliament and of the Council of 22 May 2012 on the making available on the market and use of biocidal products.

Legislation | Romania | 2014

Keyword: Institution, Authorization/permit, Hazardous substances, Pesticides, Internal trade, Enforcement/compliance, Research, Data collection/reporting, Access-to-information

Source: FAO, FAOLEX

Regulation No. 480 on Biocides (Biocide Regulation).

Legislation | Norway | 2017 (2023)

Keyword: Hazardous substances, Data collection/reporting, Internal trade, Registration, Packaging/labelling, Disinfection/disinfestation

Source: FAO, FAOLEX

Loi du 4 septembre 2015 a) concernant certaines modalités d’application et les sanctions du règlement (UE) n° 528/2012 du Parlement européen et du Conseil du 22 mai 2012 concernant la mise à disposition sur le marché et l’utilisation des produits biocides; b) relative à l’enregistrement de fabricants et de vendeurs; c) abrogeant la loi modifiée du 24 décembre 2002 relative aux produits biocides .

Legislation | Luxembourg | 2015

Keyword: Hazardous substances, Pollution control, Protection of environment, Enforcement/compliance, Inspection, Institution, Offences/penalties, Pesticides, Procedural matters, Public health, Transport/storage, Monitoring, Tax/levy

Source: FAO, FAOLEX

Circular No. 14153/161087 of 2014: Application of Article 95 of Regulation (EU) No. 528/2012 of the European Parliament and of the Council of May 22, 2012 regarding the placing on the market and the use of biocides, as amended by Regulation No. 334/2014, in the biocidal preparations under the jurisdiction of the Ministry of Agricultural Development and Food in our country.

Legislation | Greece | 2014

Keyword: Authorization/permit, Business/industry/corporations, Classification/declassification, International trade, Pesticides, Plant protection, Registration

Source: FAO, FAOLEX

Act on the taxing of plant protection products (No. 595 of 2020).

Legislation | Denmark | 2020

Keyword: Pesticides, Pollution control, Tax/levy, Plant production, Protection of environment, Biological control agents, Registration, Offences/penalties

Source: FAO, FAOLEX

Commission Implementing Regulation (EU) 2020/1036 on the non-approval of certain active substances in biocidal products pursuant to Regulation (EU) No 528/2012 of the European Parliament and of the Council.

Legislation | European Union | 2020

Keyword: Authorization/permit, Pesticides, Plant protection

Source: FAO, FAOLEX

Regulation on Biocide Law Implementation.

Legislation | Germany | 2021

Keyword: Hazardous substances, Registration, Certification, Data collection/reporting, Legal proceedings/administrative proceedings, Authorization/permit, Inspection

Source: FAO, FAOLEX

Chemicals Act (No. 61 of 2013).

Legislation | Iceland | 2013 (2019)

Keyword: Emissions, Ozone layer, Protection of environment, Pollution control, Food quality control/food safety, Toxicity/poisoning, Pesticides, Basic legislation, Hazardous substances, Risk assessment/management, Public health, Internal trade, International trade, Transport/storage, Disinfection/disinfestation, Waste management, Waste disposal, Governance, Processing/handling, Use restrictions, Packaging/labelling, Data collection/reporting, Authorization/permit, Recycling/reuse, Inspection, Oil, Enforcement/compliance, Royalties/fees, Offences/penalties

Source: FAO, FAOLEX

Amended by

Commission Delegated Regulation (EU) No. 837/2013 amending Annex III to Regulation (EU) No. 528/2012 of the European Parliament and of the Council as regards the information requirements for authorisation of biocidal products.

Legislation | European Union | 2013

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Delegated Regulation (EU) No. 492/2014 supplementing Regulation (EU) No. 528/2012 of the European Parliament and of the Council as regards the rules for the renewal of authorisations of biocidal products subject to mutual recognition.

Legislation | European Union | 2014

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Authorization/permit

Source: FAO, FAOLEX

Commission Directive 2013/44/EU amending Directive 98/8/EC of the European Parliament and of the Council to include powdered corn cob as an active substance in Annexes I and IA thereto.

Legislation | European Union | 2013

Keyword: Plant protection, Pesticides, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Regulation (EU) No. 334/2014 of the European Parliament and of the Council amending Regulation (EU) No. 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market.

Legislation | European Union | 2014

Keyword: Pollution control, Hazardous substances, Pesticides, Precautionary principle, Plant protection, Internal trade, Packaging/labelling, Authorization/permit

Source: FAO, FAOLEX

Commission Delegated Regulation (EU) 2021/525 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.

Legislation | European Union | 2020

Keyword: Cleaning agents/detergents, Consumer protection, Disinfection/disinfestation, Fish products, Food quality control/food safety, Pesticides, Toxicity/poisoning, Animal feed/feedstuffs, Monitoring

Source: FAO, FAOLEX