DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A–Green Economy
ENV.A.3 - Chemicals
Note for discussion with Competent Authorities for Biocidal Products
This document is an attempt to provide guidance in the interest of consistency, and has been drafted by the Commission services responsible for biocidal products with the aim of finding an agreement with all or a majority of the Member States' Competent Authorities for biocidal products. Please note,however, that Member States are not legally obliged to follow the approach set out in this document, since only the Court of Justice of the European Union can give authoritative interpretations on the contents of Union law.
Subject:Authorisationof skin sensitiserbiocidal products requiring PPE for non-professional users
1.- Background
(1)At severalmeetings of the Product Authorisation and Mutual Recognition Facilitation Group meeting (Restricted Session), the scope of authorisations of wood preservatives which require the use of personal protective equipment (PPE) when using these products was discussed. While the reference Member State (RMS) had authorised such products for both professional and non-professional users, some concerned Member States (CMSs) thought it necessary to restrict the use to professional users only.
(2)CMSs based the proposed restrictions on article 5(1)(b) of Directive 98/8/EC (BPD) and paragraph 73 of Annex VI thereof, where it is mentioned that a product shall not normally be authorised if the only possible method to reduce exposure for non-professional users would be the wearing of personal protective equipment .
(3)As a result, different approaches during mutual recognitionhave been followed by CMSs; some of them have already granted authorisations for both professional and non-professional use as the RMS; other MSs intended to mutually recognise the products imposing the use of PPE for non-professional users, and others have already restricted or intendto restrict the authorisation to professional use only.
(4)In addition, the restrictive approach of the biocides legislation for products classified as sensitisers for non-professionals users (DIY-market) in comparison with other consumer productswas also raised, as the risk for sensitisation could be considered similar for all of them.
(5)This discussion note aims to provide an interpretation of the legal framework regarding the authorisation of biocidal products with skin sensitising properties requiring PPE for non-professional users, as well as some criteria to be considered by CA when making decisions, in order to avoid disharmonised situations and discrepancies at the mutual recognition stage[1].
2.- Legal framework and analysis
(6)As mentioned in the recitals of the BPD, it was decided in the nineties to develop a specific framework of rules relating to the placing on the market for use of biocidal products, taking as a condition a high level of protection for humans, animals and the environment.
(7)Since the BPD publication, other pieces of legislation have been published in the field of chemical substances (REACH, CLP), but this fact does not prevent the full applicability of the specific legal framework to any product intended to be placed on the market as a biocidal product. This is also the case for the dossier evaluation to assess that the product meets the conditions for granting an authorisation (Art. 5(1) of the BPD).
(8)Article 5(1)(b) of Directive 98/8/EC states that the assessment of biocidal products shall be made in accordance with the common principles laid down in Annex VI thereof. In paragraph 73 of Annex VI, it is mentioned that "If for non-professional users the wearing of personal protective equipment would be the only possible method for reducing exposure, the product shall not normally be authorised".
(9)In addition, Article 5(1)(b)(iii) of Directive 98/8/EC mentions that a biocidal product may be authorised only if it has no unacceptable effects itself or as a result of its residues, on human or animal health, directly or indirectly (e.g. through drinking water, food or feed, indoor air or consequences in the place of work) or on surface water and groundwater.
(10)The new BPR follows a similar approach. Article 19(1)(b) refers to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI to that Regulation, and establish as a pre-requisite for authorisation that the biocidal producthas 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 (Art. 19(1)(b)iii).
(11)In paragraph 63 of Annex VI, it is also mentioned that If, for non-professional users, the wearing of personal protective equipment would be the only possible method for reducing exposure to an acceptable level for this population, the product shall not normally be considered as complying with criterion (iii) under point (b) of Article 19(1) for this population.
(12)Taking into account the above elements,the followingconclusions can be highlighted:
(a)Products falling within the definition of biocidal products in the EU are under the scope of its specific legal framework, despite other horizontal pieces of legislation on chemical substances. With regard to the risk assessment to be done for the evaluation of dossiers within the authorisation procedure, paragraph 2 of Annex VI to BPR explicitly states that The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised of chemical substances.
(b)It has been the clear intention of the legislator to maintain in the new BPR the same precautionary approach for the purpose of protecting this specific group of users (non-professionals). It is also consistent with recital (3) of the BPR, which mentions thatthis Regulation should be underpinned by the precautionary principle to ensure that the manufacturing and making available on the market of active substances and biocidal products do not result in harmful effects on human or animal health or unacceptable effects on the environment.
(c)However, the wording of paragraph 63 of Annex VI to BPR, while revised during the BPD review process, still maintains the word "normally". Thus, it can be read as a not completely rigid clause and as such, providing some room for interpretation according to specific situations resulting from the particular risk assessment of a biocidal product.
(13)Therefore, the Commission services consider that paragraph 73 of Annex VI to BPD and paragraph 63 of Annex VI to BPR can be interpreted in a way that allows a case by case approach.
(14)As such, an evaluating CA could make a decision in a more restrictive or flexible manner according to the specific information submitted by the applicant in the dossier for product authorisation (Annex IIB to BPD / Annex III to BPR) and the outcome of the corresponding risk assessment taking into account all the aspects affecting the skin sensitization potential of the biocidal product (exposure characteristics and hazard properties). Expert judgement may also be used in this process.
3. Proposed way forward
(15)Recent cases show that the lack of a common interpretation leads to disharmonised situationswhere the same biocidal product classified as skin sensitiseris authorised in different MSs for different user categories.
(16)In order to seek harmonization and avoid discrepancies during mutual recognition, where an evaluating CA seeks to grant an authorisation of a biocidal product classified considered as skin sensitiser and requiring the wearing of PPE for non-professional users, that CA should take into account the following criteria:
(a)The hazard category or sub-categories of any component included in the biocidalproduct (active substance or substance of concern) that triggers classification of the mixtureas skin sensitiseraccording to table 3.4.5 of Annex I to CLP Regulation[2]:
–Where the product contains sub-category 1A substances as defined in table 3.4.2 of Annex I to CLP Regulation (according to human evidence or animal studies), and a high frequency of occurrence of sensitization in humans and a certain severity of reactioncould be expected, a potential failure in the wearing of the PPE by non-professional users could lead to frequent and serious sensitization cases. In such a situation, a precautionary approach would be justified and the product could be restricted to professional users only.
–On the contrary, where the product contains sub-category 1 or1B substances and low to moderate frequency of occurrence of sensitization in humans and non-severe reactionscould be expected, a potential failure in the wearing of the PPE by non-professional users is unlikely tocause frequent or serious sensitization. In this case, a more flexible approach could be justified and the product could be authorised for non-professional users.
–When looking at this criterion, the CA should also consider:
- the concentration of subcategories1, 1A or 1B substances in the final product (e.g. a high concentration of a substance classified as sub-category 1 or1B in a biocidal product might pose a risk equal or higher to that of a substance in subcategory 1Abut used at low concentration).
- whether other co-formulants in the biocidal product such as common irritants might contribute to the risk of sensitization (e.g. irritants enhanceing penetration and faciliteating transportation to the immune system in the deeper layer, which in some cases is necessary for a sensitization).
(b)The likelihood of real applicability of the provisions in terms of wearing PPE (respirators, breathing-masks, overalls, gloves and goggles) by this population of users:
–The proposed PPE should be adequate for the use by non-professional users. As an example, wearing gloves seems to be an easy and reachable provision for any user, even for general safety purposes.
–The proposed PPE to wear is expected to be available for the non-professional userspopulation. Where the PPE has to meet specific requirements which might limit its availability for amateur users, the supplyof that PPE within the package of the product[3] could be considered as a condition for product authorisation.
(c)Other elements contributing to minimising exposure[4] to the biocidal product (e.g. pack design), and in particular the information provided on the product label and packaging in terms ofinstructions for use and application of the product, as well as the corresponding hazard and precautionary statementsaccording to table 3.4.7 of Annex I to CLP Regulation.
(17)Where the evaluating CA considers that the sum of the hazard profile/concentration of the component(s) qualifying a biocidal product as skin sensitiser,together with theactual exposure to the BP, the information provided on the label and the realisticuse of the PPE by this populationprovides an acceptable safe pattern of use, the authorisation could be granted for non-professional users.Available information from poison centres or epidemiology surveys on the incidence of sensitization cases among professional or non-professional users and vulnerable groups should be also used to inform this decision.
(18)Where information becoming available to any CA (RMS or CMSs) during the post-authorisation phase in accordance with Article 47 of the BPR or at the renewal of the product authorisation shows that the safety profile of the product is not anymore suitable for this usercategory, the authorisation of the productshould be reviewed and restricted to professional users only according to Article 48 of that Regulation.
(18)(19)Once this document is formally endorsed, it should be applied following the principles and cut-off dates established by the Note for Guidance on the Relevance of new guidance becoming available during the process of authorisation and mutual recognition of authorisations of biocidal products[5].
Annex: Relevant information in Annex I to CLP Regulation
Precautionary statement prevention:
P261: Avoid breathing dust/fume/ gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace
P280: Wear protective gloves/ protective clothing/eye protection/face protection (Manufacturer/supplier to specify type of equipment. — Specify protective gloves).
Precautionary statement response:
P302+ P352:IF ON SKIN:Wash with plenty of soap and water.
P333 + P313: If skin irritation or rash occurs: Get medical advice/attention.
P321: Specific treatment (see … on this label).
P363:Wash contaminated clothing before reuse.
Precautionary statement disposal:
P501:Dispose of contents/container to …
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[1]This paper does not address the cases where the assessment of the biocidal product classified as sensitiserdemonstrates a reduced exposure (e.g. a reduction in the bioavailability of free sensitisersubstance as a consequence of the formulation design) and therefore, the wearing of PPEwould not be necessary as a RMM for the safe use of the product by non-professionals..
[2]Consolidated version of the CLP Regulation available here (3.4.2.2. Skin sensitisers; pages 139 to 144)
[3]See REACH restriction in Annex XVII (entry 56) on Methylenediphenyl diisocyanate (MDI). Products can be supplied to the general public if the suppliers ensure before the placing on the market that the packaging contains the required protective gloves.
[4]In terms of level, frequency and duration of exposure.
[5] CA-July12-Doc.6.2d - Final