Biocides Regulation

Regulation (EC) No. 528/2012 of the European Parliament and oft he Council concerning the making available on the market and use of biocidal products of 22 May 2012

1. Issued by / date / date of implementation

EU / May 22, 2012 / September 1, 2013

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2. Type of legislation

European Union Regulation, to be implemented by all EU Member States according to the subsidiary principle by their means.

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3. General purpose

The Biocides regulation has the following purpose:

Functioning of the internal market by harmonisation of the regulations for making available to the market and sue of biocidal products,
High protection level for human and animal health and for the environment.

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4. Substitution relevant paragraphs

Article 17: Making available to the market of biocidal products

Biocidal products may only be made available to the market or be used, if they have been authorised according to the biocides regulation. This authorisation will be granted based upon an application of the entity making the product available to the market.

Companies can choose between various alternative procedures, depending on product and number of countries where the product will be sold. An authorisation that has been granted in one member state can by mutual recognition be extended to other member states.

Under the regulation, it is possible for applicants to apply in one step for a so called „Union authorisation“.

Article 19.1.: A biocidal product can only be authorised if the evaluation of the dossier shows that the product is sufficiently efficient and does not have unacceptable effects on human and animal health and on the environment.

Article 19 (4): The following products cannot be authorised for making available on the market for use by the general public:

Products, which according to the CLP-Regulation are classified as:

Acute oral toxicity category 1, 2 or 3,

Acute dermal toxicity category 1, 2 or 3,
Acute inhalation toxicity (gas and dust/mist) category 1, 2 or 3,
Acute inhalation toxicity (vapours) category 1 or 2,
Specific target organ toxicity category 1 with single or repeated exposure,
Carcinogens category 1A or 1B,
Mutagens category 1A or 1B, or
Toxic for reproduction category 1A or 1B

or if they

meet the criteria for being PBT or vPVB
have endocrine-disrupting properties, or
have developmental neurotoxic or immunotoxic effects

The above mentioned products can still be approved for use by the general public if non-approval would a have disproportionate negative impact for society compared to the risk of the product for human and animal health and for the environment.

Article 48: Cancellation or amendment of an authorisation: The authorisation of a product will be cancelled if, a.o. , the conditions under which it was granted are no longer valid, or if it is established that the authorisation was granted based on false or misleading information..

Authorised products shall only contain biocidal active substances that have been approved beforehand (Conditions for granting an authorisation Article 19.1). The approval of active substances is performed on union level. The active substances will first be assessed by the competent authority of a member state and the results of these assessments will subsequently be discussed with all member states in the ECHA committees and a resulting opinion will be formulated. Based upon this opinion, the approval or non-approval of an active substance will be decided by the European Commission.

Approval of an active substance is generally granted for 10 years and can be extended.

On its homepage ECHA keeps a list of active substances which have been already been approved, not approved or are still to be assessed.
Also the implementation acts regarding the individual active substances are available here.

Annex I of the regulation contains active substances that do not have properties of concern. Products that contain these active substances can be authorised via a simplified procedure. The existing Annex I can be supplemented by further active substances, if it can be proven that they do not give a cause for concern. The criteria for amending Annex I are described in Article 28 (2).

The regulation on biocidal products (BPR) plans for exclusion and substitution criteria that are to be used in the assessment of active substances.

Active substances that meet the exclusion criteria according to Article 5 of the regulation, are in principle not approved – i.e. substances with in particular following properties:

carcinogenic, mutagenic an reprotoxic substances of category 1A or 1B (according to the CLP regulation)
endocrine disruptors
substances that are persistent, bioaccumulating and toxic (PBT-Substances)
very persistent and very bioaccumulating substances (vPvB-Substances)

An approval is still possible if the active substance may be necessary for reasons of public health or public interest and no alternatives are available. In this case the approval for an active substance is granted for five years..

The regulation distinguished in Article 10 active substances that are to be replaced, with the objective these are to be substituted by feasible alternatives. Candidates for substitution are a.o. substances that meet one of the following critera:

At least one of the exclusion criteria (see. Art. 5)
Is classified as a respiratory sensitiser
Meet two of the criteria for the classification as persistent, bioaccumulating and toxic (PBT-Substance)

These substances will be approved for a maximum of 7 Years.

In the process of authorisation, for products that contain active substances with exclusion criteria and/or substances that are to be substituted a „Comparative Assessment“ according to Article 23 will be performed by the competent authority of the evaluating member state.
In this assessment, the authorities will determine if less critical authorised products or non-chemical measures are available that covert he use that was subject of the application. (e.g. Use as a disinfectant against certain bacteria). These alternative biocidal products are non-chemical alternatives may not have important economical or practical disadvantages and should have a total risk that is less. If there would be sufficient alternatives, the evaluating competent authority may reject the Authorisation. Biocidal products that have undergone a Comparative Assessment will be authorised for a maximum of 5 years. Biocidal products for which this is not the case, will be authorised or 10 years.

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5. Assessment of relevance for substitution

Biocidal products that do not possess an authorisation by any member state may not be made available to the market or be used in the EU. They must be substituted by an authorised biocidal product. In essence, the process of authorisation is a substitution process, if one considers the risk assessment and the criteria for authorisation in more detail. In addition, the regulation already starts an assessment with regard to substitution with the approval of active substances and will not approve these if sufficient alternative active substances are available.

Also in the authorisation process, products with substances that are to be substituted are critically evaluated and undergo a so called "Comparative Assessment". In the case that already authorised products with a similar effect are sufficiently available, but with less critical properties, it may be decided the reject authorisation for the more critical product.

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