09 Apr 2020
  • Adopted
  • Very high importance
  • Europe
  • Binding legal instruments (regulations, directives and decisions)
  • Entry Into Database 01 Apr 2020
  • Last revised in database 07 Apr 2020
  • Entry of act into force 01 Sep 2013


The purpose of the regulation is to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, including products containing nanomaterials, whilst ensuring a high level of protection of both human and animal health and the environment.

Key definitions

  • Biocidal product:
    1) 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. 2) 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. 3) A treated article that has a primary biocidal function shall be considered a biocidal product.
  • Treated article:
    Any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.
  • Biocidal product family:
    A group of biocidal products having (i) similar uses; (ii) the same active substances; (iii) similar composition with specified variations; and (iv) similar levels of risk and efficacy.
  • Nanomaterial:
    1) A natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm. 2) Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials. 3) For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows a)’‘particle’ means a minute piece of matter with defined physical boundaries, b) ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components, c) ‘aggregate’ means a particle comprising strongly bound or fused particles.

Data and information requirements

  • To obtain an approval of an active substance and/or a biocidal product, a dossier must be submitted to the competent authority in a chosen member state in the EU. For the active substance, the dossier must fulfill specific information requirements, described in Annex II of the regulation, whereas the biocidal product must fulfill the information requirements set out in Annex III of the regulation.
  • The data requirements consist of a Core Data Set (CDS) and an Additional Data Set (ADS). The CDS is the basis data that, in principle, must be provided for all active substances. There may, however, be cases where it is not possible to generate all data elements belonging to the CDS. This applies in special cases, where physical or chemical properties render it impossible or unnecessary to provide certain data. The ADS to be provided is determined by the physio-chemical properties of the chemical in question, for which type of products the active substance is used, and the exposure patterns that are related to that use (see paragraph 2 in Annex II and Annex III). For each endpoint in the CDS, at least one key study (or an accepted data waiving justification) must be submitted and the study has to be reliable and adequate to use for the risk assessment. According to Annex II the data submitted to support the approval of an active substance must be obtained according to the methods specified in the Test Methods Regulation. For most CDS, the relevant test methods described in the Test Methods Regulation are equivalent to OECD guidelines. If a test method is considered inadequate or not included in this regulation, it is possible to use other scientifically suitable methods; however, justification for the appropriateness of these alternative methods is required. For testing of nanomaterials the following apply: “when test methods are applied to nanomaterials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and where applicable, of the technical adaptations/adjustments that have been made in order to respond to the specific characteristics of these materials” (see paragraph 5 of Annex II and Annex III for more details).

Decision procedure

An active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet certain criteria laid down in the regulation. The approval of an active substance shall not cover nanomaterials except where explicitly mentioned. A registrant wishing to use a given nanomaterial in a biocidal product has to be granted authorisation of that active substance.

Decision-support tools

  • Risk assessment including hazard assessment, exposure assessment, dose-response assessment and risk characterization
  • Comparative assessment

Risk management procedures

  • The use of a biocidal product containing active substances shall be subject to appropriate risk-mitigation measures to ensure that exposure of humans, animals and the environment to those active substances is minimised.

Monitoring requirements

  • The Member States are required to every five years submit a report on the operation of the regulation in their respective territories, including information on the results of official controls carried out, any poisonings and, where available, occupational diseases, any available information on adverse environmental effects experienced through using biocidal products and information on the use of nanomaterials in biocidal products and the potential risks thereof.
  • On the basis of the reports received, the European Commission shall draw up a composite report on the implementation of the regulation, in particular Article 58. The Commission shall submit the report to the European Parliament and to the Council.


  • Member States shall make the necessary arrangements for official controls to be carried out in order to enforce compliance with the regulation. In order to facilitate such enforcement, manufacturers of biocidal products shall maintain appropriate documentation in paper or electronic format relevant for the quality and safety of the biocidal products and shall store production batch samples. See Article 65, paragraph 2, for the specific documentation requirements.

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Legal Requirements for different actors

  1. Application for approval


    The applicant shall submit an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance.

    The application should be sent to the European Chemicals Agency (ECHA), with information on the name of the competent authority of the Member State that it proposes should evaluate the application.

    Written confirmation that the competent authority in question agrees to do so, must also be provided.


  2. Validation of applications

    Member State Competent Authority

    Within 30 days from ECHA have accepted an application, the evaluating Member State competent authority shall validate the application if the minimum data requirements of Article 6, paragraph 1 are met, and any justifications for the adaptation of data requirements, have been submitted.

    Member states shall charge applicants fees for the services that they provide in relation to the procedures of the regulation and the competent authority shall as soon as possible after ECHA has accepted an application, inform the applicant of these fees. Where the evaluating competent authority considers that an application is incomplete, it shall inform the applicant about what additional information is required.

    The evaluating competent authority shall within 365 days of the validation of an application, evaluate the application in accordance with the requirements in Article 4 and 5, and send an assessment report and the conclusions of its evaluation to ECHA. It shall give the applicant an opportunity to provide written comments to the report within 30 days.

    For biocidal products where nanomaterials are used, authorization to use the product cannot be given, unless the risk to human health, animal health and the environment has been assessed separately for the nanomaterials.

  3. Preparation of opinion

    The European Chemicals Agency (ECHA)

    Within 270 days after receiving the conclusions from the evaluation of an application of approval of an active substance, ECHA shall prepare and submit an opinion to the European Commission.

  4. Approval of active substances

    The European Commission

    After receiving an opinion from ECHA regarding approval of an active substance, the European Commission shall either adopt an implementing regulation providing that the active substance is approved or adopt an implementing decision that the substance is not approved. The European Commission shall keep and update a list of approved active substances. 

  5. Labelling

    Authorization holders

    Authorization holders shall ensure that biocidal products containing nanomaterials, are labelled clearly with information on the nanomaterial, any specific related risks, and, following each reference to nanomaterials, the word ‘nano’ in brackets. 

Legislative History

  1. Legislative proposal COM(2009)0267

    December 06 th, 2009

    Legislative proposal prepared by the European Commission

    Legislative Observatory European Parliament
  2. Text adopted by Parliament, 1st reading

    September 22 th, 2010

    Text adopted by Parliament, 1st reading/single reading

    Legislative Observatory European Parliament
  3. Council position

    June 21 th, 2011

    Council position on Parliament's 1st reading

    Legislative Observatory European Parliament
  4. Text adopted by Parliament, 2nd reading

    January 19 th, 2012

    Text adopted by Parliament, 2nd reading

    Legislative Observartory European Parliament
  5. Final act signed

    May 22 th, 2012

    Final act is signed by the European Parliament and the Council

  6. Final act published

    June 27 th, 2012

    Final act published in the Official Journal of the European Union

  7. Entry of act into force

    September 01 th, 2013

    Biocidal Products Regulation enters into operation and the first list of approved suppliers is published. 

    Union authorisation is available for all products containing a new active substance, as well as for product-types 1, 3, 4, 5, 18 and 19

    ECHA Newsletter No 4 August 2013
  8. List of approved suppliers

    September 01 th, 2015

    All active substance suppliers must be on the list of approved suppliers in order to stay on market

    ECHA Newsletter No 4 August 2013
  9. Synthetic amorphous silicon dioxide (nano)

    October 11 th, 2016

    Biocidal Products Commitee adopts opinion on approval of synthetic amorphous silicon dioxide (nano), surface treated as active substance in product type 18

    ECHA 2016
  10. Product-types 2, 6 and 13

    January 01 th, 2017

    Union authorisation available for product-types 2, 6 and 13

    ECHA Newsletter No 4 August 2013
  11. Product-types 7, 8, 9, 10, 11, 12, 16 and 22

    January 01 th, 2020

    Union authorisation available for remaining product-types 7, 8, 9, 10, 11, 12, 16 and 22

    ECHA Newsletter No 4 August 2013

Nano-specific test requirements

The regulation provides valuable data


Challenges for ecotoxicological testing

Challenges for interpretation definition of nanomaterials

Challenges for identification of treated articles with nanomaterials