2. Legislation

2.1. EU/NL framework

In general, in the European context, active substances are assessed to determine at least one realistic safe use within each product type for which authorisation is requested. According to the Biocidal Products Regulation, 22 product types are distinguished (see paragraph 6 of this chapter). The ECHA website identifies all the active substances that have been or are being assessed in this European review programme and for which product type(s) they are being assessed.

The specific NL information requirements or exposure and risk assessments (national specific elements), described in the NL part of the BPR Evaluation Manual, is reverted to where no EU procedure has been laid down or where specific national information requirements are necessary.

The responsibility for establishing and maintaining the specific national framework for the assessment of biocides lies with the Ctgb.

Scope of the BPR

The BPR art. 3 defines a ‘biocidal product’ as being:

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”

Despite this definition, in practice it is not always instantly clear whether a product falls within the scope of the BPR.

Traditionally borderline cases arise on the interface with plant protection products, medicines, cleaning agents,  food additives. Medicines, medical devices, cosmetics and plant protection products are covered by alternative, specific directives and regulations. Since these products are regulated by other EU legislation, these product categories are excluded from the BPR. On the interfaces between e.g. the Commodities Act, the Medicines Act, the Medical Devices Act, and the Biocidal Products Regulation, there are products that cannot be easily assigned to one specific group.

Biocidal products

The situation is now as follows:

• European harmonized methodologies and appointments are implemented as much as possible by The Netherlands.
• For methodologies and agreements not yet harmonized, The Netherlands adheres to those methods that have been used until now. These are the national interpretation of gaps used by the Ctgb until a harmonized methodology is adopted in the EU.
• If a harmonized methodology or appointment has been established but The Netherlands has good reasons to deviate, Ctgb adopts a national specific derogation. That derogation shall be notified to the EU.
• If a national specific element is defined in Dutch legislation, then the responsibility for nationally specific derogation is not taken by the Ctgb but by the Dutch government.

The BPR delineates the space that Member States have for specific derogations. The grounds on which a Member State may derogate from the conditions of the authorisation to recognize is explicitly defined in Article 37 of the BPR:

• The grounds for derogation of article 37, paragraph 1 are:
  • the protection of the environment; 
  • public policy or public security;
  • the protection of health and life of humans, particularly vulnerable groups, or of animals or plants;
  • the protection of national treasures of artistic, historic or archaeological value;
  • the target organisms are not present in harmful quantities.
• Article 37 paragraph 4: the Member State may refuse authorisation for animal welfare reasons for PT 's 15 ( Avicides ), 17 ( Piscicides ) and 20 (vertebrates other than rodents).

Where article 19(1) point b stipulates that it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria:
(i) the biocidal product is sufficiently effective;
(ii) the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates;
(iii) the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects;
(iv) the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:

• the fate and distribution of the biocidal product in the environment,
• contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation,
• the impact of the biocidal product on non-target organisms,
• the impact of the biocidal product on biodiversity and the ecosystem;

Where article 19(2) stipulates that the evaluation of whether a biocidal product fulfils the criteria set out in point (b) of paragraph 1 shall take into account the following factors:
(a) realistic worst case conditions under which the biocidal product may be used;
(b) the way in which treated articles treated with the biocidal product or containing the biocidal product may be used;
(c) the consequences of use and disposal of the biocidal product;
(d) cumulative effects;
(e) synergistic effects.

Where article 19(5) stipulates that notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation.
The use of a biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised. The use of a biocidal product authorised pursuant to this paragraph shall be restricted to Member States in which the condition of the first subparagraph is met.
In general the starting points for decision making as regards the effects on humans and the environment are presented in the Common Principles (Annex VI to BPR 528/2012). In summary, in relation to the criteria set out in points (iii) and (iv) of Article 19(1)(b), the evaluating body shall combine the conclusions arrived at for the active substance(s) and the substances of concern to produce overall summary conclusions for the biocidal product itself. A summary of the conclusions in relation to the criteria set out in points (i) and (ii) of Article 19(1)(b) shall also be made.
The evaluating body shall, on the basis of the evaluation carried out in accordance with the Common Principles (Annex VI to BPR 528/2012), come to a conclusion as to whether or not it is established that the biocidal product complies with the criteria laid down under point (b) of Article 19(1).

Active substances

According to the BPR528/2012 article 4 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 the criteria laid down in point (b) of Article 19(1) taking into account the factors set out in Article 19(2) and (5). An active substance that falls under Article 5 (exclusion criteria) may only be approved for an initial period not exceeding five years.

2.2. Transitional legislation frame work

The goal of the EU framework is to ensure that the legislation pertaining to biocidal products in the various member states is completely harmonised by 2024(1). This means that, until 2024, national legislation can remain in force for biocidal products based on existing substances (i.e. substances in biocidal products which were already on the market before 14 May 2000) not yet included on the Union list of Approved Active Substances or Annex I of the BPR (512/2012).

For products containing such existing substances that have not yet been approved, transitional legislation in The Netherlands applies and the procedure of the transitional legislation frame work should be followed.

There is no transition period for biocidal products based on new substances. These must be evaluated in accordance with the rules of the Biocidal Products Regulation without any delay, and products based on such new substances cannot be registered until the active substance has been approved. In case the active substance has not been included in the European review programme an application for authorisation of this product cannot be submitted. First, a dossier for the active substance should be submitted and the substance must be approved.