Regulation 2012/528 - Making available on the market and use of biocidal products - Main contents

SUMMARY OF:

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

SUMMARY

Biocidal products (household disinfectants, insecticides and other chemicals) are used to suppress pests (parasites, fungi, bacteria, etc.) or to protect materials. However, as their properties can pose risks to humans, animals and the environment, they are regulated at European Union level.

WHAT DOES THIS REGULATION DO?

It harmonises the EU’s rules concerning the sale and use of biocidal products, while ensuring high levels of protection of human and animal health and of the environment.

KEY POINTS

Approval

In order to be allowed to be sold in the EU, all biocidal products require a permit. The active ingredients that they contain must also be approved.

The evaluation of biocides' active substances is carried out at EU level. For each active substance that needs to be evaluated, an EU country is appointed ‘rapporteur’ . It is responsible for producing an evaluation report which is then discussed by all the EU countries with a view to reaching a decision at EU level to approve (or not) the substance.

Active substances that meet the exclusion criteria are not approved. These are substances that are carcinogenic, mutagenic or toxic to reproduction, endocrine disruptors, persistent*, bioaccumulative* and toxic* (PBT) or very persistent and very bioaccumulative (vPvB). Exemptions are possible, however, if the risks are negligible.

The risks associated with nanomaterial biocides* 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.

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 with the ECHA: if the product is deemed safe, 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 country. If permission is granted, companies can put the product on the market of other EU countries based on the principle of mutual recognition of the authorisation of the product.

There is also a simplified authorisation procedure for the least harmful products that meet certain criteria, such as those that do not contain substances of concern or nanomaterials.

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 therefore set up an information system (Register for Biocidal Products).

Treated objects

The regulation covers articles that have been treated with or containing a biocidal product (such as furniture and food packaging). Items can only be treated with active substances that have been approved in the EU and must be labelled as such.

WHEN DOES THE REGULATION APPLY?

From 1 September 2013.

BACKGROUND

Biocides

Biocidal products regulation

KEY TERMS

• * 

  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.

• * 

  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.

• * 

  Toxic: substances which may harm the environment or health if inhaled, ingested or absorbed through the skin.

• * 

  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).

REFERENCES

RELATED ACTS

Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, pp. 1-84)

Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 93, 3.4.2013, pp. 85-152)

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)

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)

last update 26.10.2015

This summary has been adopted from EUR-Lex.