ECHA

Clear exclusion criteria, a process for candidates for substitution and simplified authorisation are some of the examples of how the Biocidal Products Regulation encourages applicants to choose safer active substances for biocidal products.

In addition to improving the functioning of the biocidal products market in the EU, the Biocidal Products Regulation aims for a high level of protection for humans and the environment. To reach this, there is a two-step approval and authorisation process to ensure the safe use of biocidal products. Firstly, the active substance needs to be approved and only after that can the biocidal product be authorised.

Exclusion criteria for active substances

The Biocidal Products Regulation includes specific exclusion criteria for active substances that are harmful for human health and/or the environment. The basic principle is that active substances that fulfil any of the criteria cannot be approved, except if specific conditions are met.

Therefore, active substances that are

• carcinogenic, mutagenic or toxic for reproduction (category 1);
• endocrine disrupting;
• persistent, bioaccumulative and toxic; or
• very persistent and very bioaccumulative

will not be approved.

However, the regulation includes a derogation that states that an active substance that fulfils at least one of the exclusion criteria can be approved for a short period of time if it is needed to prevent serious harm to human health, animal health or the environment, or if not approving it would have a disproportionately negative impact on society. It also requires strict risk mitigation to make sure that any exposure of humans, animals and the environment to the biocidal product containing a harmful active substance is minimised.

This also affects the applicant when they apply for product authorisation. Union authorisation and simplified authorisation cannot be granted for products that contain active substances meeting any of the exclusion criteria.

Substitution criteria for active substances

The regulation also introduces substitution criteria which encourages applicants to replace harmful active substances used in their biocidal products with safer ones.

For the active substances that meet any of the substitution criteria, a public consultation is organised as part of the approval process.

An active substance will be considered as a candidate for substitution if

• it meets at least one of the exclusion criteria;
• it is classified as a respiratory sensitiser;
• its toxicological reference values are significantly lower than those of the majority of approved active substances for the same product-type and use;
• it meets two of the criteria to be considered as persistent, bioaccumulative and toxic;
• it causes concern for human or animal health and for the environment even with very restrictive risk management measures; or
• it contains a significant proportion of non-active isomers or impurities.

Public consultation during active substance approval

It is the evaluating competent authority that assesses the active substance, analyses if it fulfils any of the substitution criteria and indicates in their evaluation report whether it is a potential candidate for substitution. The assessment is based on the intrinsic properties of the active substance in combination with the use.

Based on the competent authority's assessment, ECHA launches a public consultation on the potential candidate for substitution. The aim of the public consultation is to gather any relevant information, including suitable alternatives for the harmful active substance, from any interested party.

Public consultations last for 60 days and ECHA will take the information received into consideration when drafting its opinion on active substance approval.

The European Commission will not approve any active substances which are candidates for substitution for more than seven years at a time. If the active substance meets one or more exclusion criteria it can only be approved for five years at a time.

The first public consultations under the Biocidal Products Regulation were launched at the end of 2013 and completed during the first months of 2014. All non-confidential information received during the public consultations is published on ECHA's website.

The input containing confidential information is only made available to the Biocidal Products Committee, its working groups and the Member State competent authorities.

Assessing hazards before product authorisation

The hazardousness of a biocidal product is evaluated when an application for product authorisation is made.

The evaluating competent authority carries out a comparative assessment for any biocidal product containing active substances that are candidates for substitution before finalising their evaluation report.

This means that the evaluating competent authority assesses whether there are other authorised biocidal products or non-chemical control or prevention methods available with significantly lower risk for human and animal health and the environment.

The new biocidal product will not be approved if there is an alternative which is sufficiently effective and does not cause significant economic or practical disadvantage. There must also be sufficient chemical diversity among the active substances to minimise the occurrence of resistance.

For a biocidal product containing an active substance that is a candidate for substitution, an authorisation can be granted for a maximum of five years at a time. However, the authorisation can contain restrictions, meaning that the biocidal product is authorised, for example, for only certain specified uses.

Simplified authorisation encourages the use of safer products

To encourage the use of safer biocidal products with more favourable environmental and human and animal health profiles, the Biocidal Products Regulation introduced simplified authorisation which is a new and faster way of obtaining product authorisation.

To be eligible for simplified authorisation, all the active substances contained in the biocidal product must be listed in Annex I of the regulation. Additionally, the product cannot contain any substances of concern or any nanomaterials; it must be sufficiently effective; and handling of the product must not require personal protection equipment.

Further information:

• Active substances which are candidates for substitution
• Public consultations on potential candidates for substitution
• Exclusion criteria for active substances
• Simplified authorisation

Text by Päivi Jokiniemi

Top image: Fotolia

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