Note 1 for Discussion with Competent Authorities for Biocidal Products

Note[1] 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 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:Handling “carriers” in the authorisation of biocidal products

1.- Background and purpose of the document

(1)In the context of an agreement reached by the Coordination Group (CG) on a formal referral[2], CG members identified the need to develop some guidance on how to address in a harmonised way the handling of “carriers” in the authorisation of biocidal products.

(2)This note outlines a proposal addressing that identified need.

2.- Relevant provisions in EU legislation and available guidance documents

(3)For the definitions of the terms "substance", "mixture" and "article", Article 3(2) of the Regulation (EU) No 528/2012[3] (the "BPR") refers to the definitions in Regulation (EC) No 1907/2006[4] ("REACH"). Consequently, the REACH guidance on borderline cases between substance/mixture/article[5] should be considered in order to address borderline cases between articles and mixtures (or substances).

(4)According to Article 3(1)(a) of the BPR, a treated article that has a primary biocidal function shall be considered as a biocidal product. Guidance on the delimitation between treated articles and biocidal products is provided for inthe note for guidance CA-Sept13-Doc5.1.e.Rev1[6] on "Frequently asked questions on treated articles". Any relevant Commission decision adopted in accordance with Article 3(3) of the BPR[7] should also be considered.

3.- Carriers and biocidal products – proposed way forward

(5)Document CA-Sept13-Doc5.1.e.Rev1specifies that treated mixtures or substances with a primary biocidal function are “classical” biocidal products (mixtures). Consequently, while a solvent or inert inorganic constituent (i.e. silicium dioxide or aluminium oxide) might be considered as a carrier component in some biocidal products that are mixtures, those “carriers” however fail the REACH criterion for articles[8]. Therefore, the rules for classification, efficacy assessment and description of the composition of these mixtures are applicable to the biocidal mixture as a whole.

(6)Biocidal products which, in the form in which they are supplied to the user, consist in

(a)an article that meets the REACH criteria to be an article and

(b)which has been treated with, or intentionally incorporate one or more biocidal products, and

(c)which is to be regarded as a treated article having a primary biocidal function[9],

would consequently present a “carrier component”.

(7)Two types of combinations of a biocidal mixture/substance and a carrier component may be further distinguished in the context of product authorisation:

(8)Type A:Biocidal products in which the carrier component fulfils the function of a simple carrier matrix, allowing for an easier handling, application or delivery of the biocidal mixture/substance (“carrier-based biocidal products”). Normally the carrier would consist of one or more material(s) having undergone a form-giving process (plastics, tissues, cellulose or paper). Examples include (window)stickers, (gas generating) strips or disinfecting wipes(even if they could have a collateral cleaning function).

(9)Type B:Biocidal products that aretreated articles where the article fulfils, besides the primary function of a biocidal nature, a secondary function beyond a mere carrier function due their form, surface or design (“functional biocidal products”). Examples include[10] treated nets, clothing, handkerchiefs, covers, bed lining or facial masks.

(10)This category includes either products in which the biocidal mixture/substance is:

(a)Just coated on the surface or impregnated in the outer layer of the carrier component. E.g. coated repelling hair bands or bracelets, cardboard boards painted with an insecticide or a horse rug where only the outer layer is impregnated with an insecticide or an insect repellent.

(b)Impregtaned in the whole carrier component, from which it is released to the carrier's surface to exert the biocidal effect. E.g. silicone repellent bracelets, insecticide mosquito nets, handkerchiefs impregnated with disinfectant, etc.

(11)For the sake of completeness, while not commonly considered as treated article but rather a combination of a container and a mixture, a third category of biocidal products should be considered.

(12)Type C:Biocidal products in a specific type of packaging (container) that is not removed before use (i.e. to prevent contact with users). Examples include hangers containing a biocidal liquid in an internal compartment (Anti-moth biocidal mixture closed in a plastic device/crochet/hanger) or prefilled bait stations or (pressurized)cartridges.

(13)The annex to this document provides for a flow chart summarising the elements to be considered in order to allocate a biocidal products to one of the three above-mentioned categories.

4.- Practical implementation

4.1.- Describing the productcomposition

(14)For types Aand B biocidal products, CG members already agreed[11] that the carrier component should not be considered as a part of the composition of the biocidal product. Therefore, it should not be considered for the calculation of the AS concentration to be indicated in the SPC[12].

(15)For biocidal products of type C, only the composition of the biocidal mixture/substance should be considered for the calculation of the AS concentration to beindicated in the SPC.

4.2.- Classification and labelling

(16)A treated article that has a primary biocidal function shall be considered a biocidal product in accordance with article 3(1)a of the BPR. Consequently, the labelling of treated articles foreseen by article 58 cannot be applied to these biocidal products[13].

(17)In accordance with article 69 of the BPR, biocidal products are classified, packaged and labelled in accordance with Regulation (EC) No 1272/2008[14] (the "CLP Regulation"), as well as in accordance with the approved summary of product characteristics (SPC), which contains in particular any “hazard and precautionary statements” (see Article 22(2)(i) of the BPR).

(18)It is proposed thatthe hazard and precautionary statements, as well as any other labelling elements deriving from the CLP Regulation,are based:

(a)For types Aand B biocidal products, and in line with previous CG agreements[15], on the classification of the biocidal mixture/substance used in the product only[16].

There may be cases where the classification of a type B product based on the classification of the biocidal mixture/substance might lead to some P-statements that would prevent the product from being authorised for the general public (e.g. P-280 – wear gloves). It has to be noted though that aP-statement that has been proven unnecessary in the risk assessment should be left out of the SPC and of the label[17].

Where relevant, document CA-Sept13-Doc.6.2.a – Final.Rev1[18] would also apply.

(b)For type C biocidal products, on the classification of the biocidal mixture contained in the article acting as the packaging.

(19)For the sake of consistency, the content of the ASto be indicated in section 2 of the SPC, as well as on the label pursuant toArticle 69(2)(a) of the BPR,should be the same which is considered for classification purposes.

4.3.- Describing the “carrier component”

(20)For type Bbiocidal products, the chemical composition of the mixture could be specified in the application under IUCLID section 2.3 (this section also includes the field ‘type of formulation’) including the carrier material, and in such a way, that the composition of the mixture used to treat the article may easily be deduced[19].

(21)In addition, in order to allow for a maximum flexibility at the meta-SPC level of a biocidal product family (BPF)[20], it is proposed thatfor all types (A,B,C),a clear description of the carrier component specifications should be provided under IUCLID section 12.3 regarding the packaging of the biocidal product. (e.g. "ready for use bait station with 0.5cm diameter opening", for a type C product).

(22)These specifications should cover those macroscopic characteristics of the carrier (e.g. colour, mesh size for nets, size of moth paper when in contact with skin,etc...) that influence the exposure or efficacy of the product as supplied to the end-user.

(23)In case the article is made up of a combination of different materials, the specifications for each material, as well as the method used to combine these different materials, should also be provided.

(24)The identity part of the PAR should include a detailed description of the carrier, ensuring that clear information is provided regarding:

(a)the carrier dimensions and mass,

(b)the mass of the amount of biocidal mixture/substance on the carrier[21],

(c)those characteristics that may influence exposure, efficacyphysic-chemical properties, shelf life, etc.

(25)The draft SPC prepared by the reference MS or the e-CA in case of UA, should also include abrief description, excluding any confidential information:

(a)For type “C” products, under the packaging field of the tables describing the intended uses in section 4,

(b)For types “A” and “B” products, under section (6 "Other information").

(26)The classification of applications for a change affecting the carrier component of a biocidal product should be considered on a case by case basis, depending on the extent of the assessment to be performed. Where required, applicants can request an ECHA opinion in accordance with Article 2 of Regulation (EU) No 354/2013[22] (“the changes Regulation).

4.4.- Physical-chemical properties

(27)Product stability tests for biocidal products of type A and B should be carried out with the product as it is supplied to the user.

(28)Tests for all other physical-chemical properties may be performed with the substance/mixture before it is applied to the carrier component.

4.5.- Exposure assessment

(29)For all types biocidal products (A, B and C), tests (where required) should be carried out with the product as it is supplied to the user.

(30)For type C biocidal products,some tests may be carried out on the mixtureonly (e.g. dermal absorption).

4.6.- Efficacy testing

(31)Unless otherwise recommended in agreed EU guidance[23], laboratory trials for type A and B biocidal products should be carried out on a sample of the biocidal product (mixture and carrier). Where required[24], simulated-use or field trials for type A and B biocidal products must however always be carried out with the product as supplied to the user.

(32)Laboratory trials for type C product can be carried out only on the mixture, while simulated-use or field trials for type C biocidal products shall be carried out, where relevant, on the product as supplied to the user.

(33)For some product- types, the test requirements are specifically stated in the efficacy guidance for the relevant PT (e.g. PT 1 and 2 for "disinfectant towelettes/wipes"). For these uses, the test requirements according to the relevant PT guidance should be followed.

5.- Action requested

(34)The Commission services invite the CA meeting to endorse this document as agreed by the Coordination Group.

Annex

1/8

[1]This note has been tabled for agreement at the CG-20 meetingon 15 November 2016 (document CG-20-2016-17 AP 13.1). Should the CG meeting result in any changes to the current version, a rev1 version will be made available on Circabc.

[2]See minutes of CG-12, available at

[3]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(OJ L 167, 27.6.2012, p. 1).

[4]Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

[5]See “Guidance on requirements for substances in articles” (Chapter 2), available at

[6]Available at

[7]List of all published decisions available at

[8]In accordance with the REACH guidance a bulk chemical fails the “shape, surface and design” criterion of an object: shape, surface and design are not to be confused with physical characteristics that result from the chemistry of the material(s), and furthermore no production step is involved in the deliberate determination of the shape, surface or design.

[9]To be determined in accordance with “CA-Sept13-Doc5.1.e.Rev1.

[10]Insofar as these articles have a primary biocidal function in accordance with CA-Sept13-Doc 5.1.e.Rev1.

[11]See Minutes CG-10 (informal referrals) and CG-12 (formal referrals).

[12]It is of course important to consider the carrier component, and the distribution of the active substance in the matrix, when carrying out the risk assessment (see sections 4.5 below).

[13]For the article (carrier) itself it has to be checked on a case by case basis if provisions of Article 58 of the BPR have to be fulfilled (rare cases).

[14]Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (OJ L 353, 31.12.2008, p. 1.).

[15]See CG agreement on Raid Fly Killer Window Sticker, available at

[16]As thebiocidal mixture/substance interacts at the surface of the carrier, its hazard properties will be relevant.

[17] See document CA-May13-Doc.5.4-Final.rev1 on "Classification and labelling of biocidal products", available at

[18]"Authorisation of biocidal products classified as skin sensitisers requiring PPE for non-professional users", available at

[19]In order to implement this, in addition to the compositional information a clarifying document can be attached in IUCLID section 2.3, which could also refer to section 12.3 for more details.

[20]This information could be included in the information regarding the type of formulation. However, in the case of a BPF and since one meta-SPC cannot cover multiple types of formulation, this would lead to a multiplication of meta-SPCs if multiple articles were to be included in a BPF with this approach.

[21]E.g. for a disinfecting wipe it may be relevant to know that every wipe contains x g of the active substance. This can then be used when making the risk assessment or when deciding which dose/application should be authorised (e.g. 1 application = 2 wipes).

[22]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, p. 4).

[23]See for instance ECHA “Transitional Guidance on Efficacy Assessment for Product Types 1-5, Disinfectants”, which for disinfecting wipes, the suspension test (phase 2 step 1) “should be done preferably with the liquid extracted from the wipes, or if difficult to extract, use the liquid as it is before it is added to the wipes.”Note: When the ECHA Efficacy guidance general part B/C and/or the relevant PT-specific chapters will be finalised, this new document should be considered.

[24]For hard surfaces disinfectants in PT2, phase 3 tests (i.e.field tests) are optional (Cf. section 3.3.2.1. of ECHA “Transitional Guidance on Efficacy Assessment for Product Types 1-5, Disinfectants”.)