32012R0528

WHAT IS THE AIM OF THE REGULATION?

It harmonises the rules in the European Union (EU) concerning the sale and use of biocidal products¹, while ensuring high levels of protection of human and animal health, and of the environment.

KEY POINTS

Active substance approval

• In order to be allowed to be sold in the EU, all biocidal products require a permit. The active substances that they contain must be approved or included into Annex I of the regulation.
• The evaluation of biocidal active substances is carried out at the EU level. For each active substance that needs to be evaluated, an EU Member State ‘rapporteur’ is appointed. The rapporteur is responsible for producing an assessment report which is peer-reviewed by the other Member State representatives within the Biocidal Products Committee (BPC) of the European Chemicals Agency (ECHA). The BPC prepares an opinion of the agency, which is the basis for the European Commission’s decision to approve (or not approve) the substance.
• Active substances that meet the exclusion criteria are not approved. These are substances that are:
  • carcinogenic, mutagenic or toxic to reproduction;
  • endocrine disruptors²;
  • persistent³, bioaccumulative⁴ and toxic⁵; or
  • very persistent and very bioaccumulative.
• Exemptions are possible, however, when:
  • the risks from exposure to the substance are negligible;
  • the substance is essential in preventing or controlling a serious danger to human health, animal health or the environment; or
  • non-approval would cause a disproportionate negative effect on society when compared to the effects caused by the use of the active substance.
• The risks associated with nanomaterial biocides⁶ must be specifically assessed.
• The approval of an active substance is granted for a period not exceeding 10 years.
• Approved active substances are listed on the European Chemicals Agency (ECHA) website.

Product authorisation

Once an active substance is approved, companies must apply for permission to place their products on the market in one of the following ways.

• By submitting a request for EU authorisation to the European Chemicals Agency: if the product is deemed safe following the assessment by a competent evaluating authority of a Member State and the granting of an authorisation by the Commission, it can be sold directly throughout the EU without the need to obtain specific national authorisation.
• By submitting a request for national authorisation, if the product is to be sold in a single Member State. If an authorisation is granted, companies wishing to place the same product on the market of other Member States can apply for the principle of mutual recognition of the authorisation of the product.

There is also a simplified authorisation procedure for the least harmful products which meet specific conditions (contain no substances of concern, no nanomaterials or are sufficiently effective and their handling does not require the use of personal protective equipment).

By way of exception, biocidal products containing active substances which were already on the market in May 2000 and are included in the work programme for the examination of existing biocidal active substances can be made available on the market and used in accordance with national laws of each Member State pending the final decision on the approval of the active substance(s) they contain.

Data sharing

To minimise costs and the use of animal testing, the regulation requires the sharing of data on approved substances and products authorised in the EU. The agency has set up an information system (register for biocidal products) that contains all the information on applications, assessments and authorisations or approvals.

Treated articles

The regulation covers articles that have been treated with or incorporate a biocidal product (such as furniture and paints). Treated articles can only be treated with active substances that have been approved in the EU and must be labelled following specific rules.

Delegated and implementing acts

The European Commission has adopted many delegated and implementing acts in relation to Regulation (EC) No 528/2012.

Of particular note are:

• Delegated Regulation (EU) 2017/2100 which sets out the scientific criteria for determining endocrine-disrupting properties;
• Delegated Regulations (EU) No 1062/2014, (EU) 2017/698 and (EU) 2019/157 on the work programme for the systematic examination of all existing active substances contained in biocidal products.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 1 September 2013.

BACKGROUND

For more information, see:

• Biocides (European Commission)
• BPR Legislation (European Chemicals Agency).

KEY TERMS

1. Biocidal products: products such as household disinfectants, insecticides and other chemicals used to suppress pests (parasites, fungi, bacteria, etc.) or to protect materials. As their properties can pose risks to humans, animals and the environment, they are regulated at the EU level.
2. Endocrine disruptors: chemicals which under certain conditions can affect the hormonal system of humans and animals.
3. Persistent: these are chemicals that persist in the environment (i.e. do not break down) and thus may damage human health. The pesticide DDT is an example.
4. Bioaccumulative: the accumulation of a substance such as a chemical in an organism. Bioaccumulation occurs when this substance is absorbed faster by the organism than it is eliminated.
5. Toxic: substances which may harm the environment or health if inhaled, ingested or absorbed through the skin.
6. Nanomaterial biocide: a biocide produced using a nanomaterial. Nanomaterials are chemical substances or materials that are manufactured and used on a very small scale. Nanomaterials have unique and more pronounced characteristics compared to the same material without nanoscale features (source: European Chemical Agency).

MAIN DOCUMENT

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 (OJ L 167, 27.6.2012, pp. 1-123)

Successive amendments to Regulation (EU) No 528/2012 have been incorporated into the original text. This consolidated version is of documentary value only.

RELATED DOCUMENTS

Commission Implementing Regulation (EU) No 88/2014 of 31 January 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 (OJ L 32, 1.2.2014, pp. 3-5)

Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, pp. 4-13)

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, pp. 33-79)

See consolidated version.