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:Linking biocidal label claims and the product authorisation

1.- Background and purpose of the document

(1)Use of label claims[2]as a communication tool towards the end-user seems to be current practice, particularly in some product-types (PTs), in the existing products placed on the market in accordance with the national transitional rules. This practice needs to be properly addressed when granting product authorisations according to Regulation (EU) No 528/2012[3] (the "BPR"), to prevent a distortion betweenproducts placed on the market of the individual Member States (MSs) for very similar uses.

(2)At the 17th meeting of the Coordination Group (CG), CG members discussed how label claims for disinfectants should be handled in the context of product authorisation in order to find a harmonised way forward and avoid mutual recognition (MR) disagreements.

(3)This note outlines a harmonised approach to handle label claims at product authorisation in a general manner (i.e. for any product-type), while avoiding additional layers of complexity to the MR process and ensuring proper enforcement.

(4)It has to be noted that as non-biocidal label claims[4] are outside the scope of the BPR and are therefore not listed in the SPC[5], non-biocidal claims are not in the scope of this paper.

2.- Analysis of the relevant provisions in the BPR

(5)While product labels are not part of the product authorisation, section 12 of Annex III requires the submission of example labels[6] with each application for product authorisation. Therefore, apart from the mandatory information referred to in Article 69(2) of the BPR, any intended label claim may be identified by applicants at the submission stage.

(6)Article 69 of the BPR gives the authorisation holder (AH) the full responsibility of ensuring that biocidal products are classified, packaged and labelled in accordance with the summary of the product characteristics (SPC), Regulation (EC) No 1272/2008[7]and the restrictions referred to in Article 69(2) in terms of avoiding misleading information and some forbidden indications.

(7)Article 69(2) further specifies the minimum information that shall be provided on the labels (indents a to h). Thusother information, such as claims, can be added by the AH to the label provided that it complies with the requirements referred to in the paragraph above. This means that AHs are responsible of the substantiation of any claim made on the label from an enforcement[8] point of view.

(8)From that enforcement point of view, Article 69(1) of the BPR requires that label claims referring to the technical features of the product (e.g. efficacy rate against a given target organism) should be in accordance with the SPC. The objective of this provision is not that the label claims have to be listed in the SPC, but to ensure that the label claims are substantiated by the information provided by the SPC, which summarises the content of the product authorisation.

(9)Articles 30(3)(a), 34(4) and 44(1) of the BPR refer to the product assessment report(PAR)[9] summarising the conclusions of the assessment of the application, which is the basis for the generation of a SPC. Therefore, for the purpose of enforcement of label claims,it is proposed that the reference to the SPC is interpreted in a wider manner, in so far as the SPC compiles the conclusions of the documents underlying the assessment of the application (i.e. the PAR)[10].

(10)Article 67(2) and (4) requires that both the SPC and the PAR have to be made publicly available by ECHA after product authorisation, so both documents should be available to national competent authorities for enforcement purposes[11].

3.- Proposed way forward

(11)Considering that:

(a)Label claims are a communication tool to the end user (e.g. consumer) that might be subject to changes over time and requires some flexibility for companies,

(b)The label of a biocidal products is not part of the product authorisation,

(c)Including too specific information related to label claims in the SPC might trigger:

–Applications for a change in order to adapt the product authorisation to any evolution of the label claims,

–Numerous discussions in MR or UA procedures,

–Some inconsistencies between products authorised under the BPR and existing products placed on the market of MSs according to the transitional rules,

(d)The AH is fully responsible of the accuracy of any information provided on the label,

(e)Such accuracy should be subject to enforcement and where relevant, to the penalties applicable in each MS,

(12)It is proposed that label claims are not reflected in the product authorisation (SPC) and therefore will not be part of the mutual recognition procedure.

(13)For enforcement purposes, and taking into account that:

(a)Intended label claims should be identified in the application for product authorisationand assessed by the applicant in the relevant section of the draft PAR,

(b)The evaluating body shouldproperly address in the PAR the conformity of any intended claims that are linked to the intended uses in the draft SPC againstEU applicable guidance[12],

(c)The PAR i) is the key document supporting the draft SPC and both documents are considered together in the context of MR and Union Authorisation (UA) and ii) can also be updated according to any new information assessed in the context of an application for a change or for renewal,

(d)The current structure of the SPC template[13] does not include any specific field to include information which might support the label claims associated to one or more of the target organisms in the authorised uses listed under section 4,

(e)Section 6 of the SPC would allow though making a generic reference to the section of the PAR where the conformity of the intended claims in the application is addressed (e.g. "See chapter 2.2.5 of the PAR - Efficacy against target organisms - for further information on the label efficacy claims"),

(f)Both the PAR and the SPC will be available to enforcement authorities,

(14)It is proposed that:

(a)Enforcement of label claims is performed against the information available in the SPC (i.e. target organisms in the authorised uses) and the relevant sections in the PAR and

(b)Where this information substantiates the label claim, the biocidal product should be considered as compliant with the requirements in Article 69(1) of the BPR.

4.- Action requested

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

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[1]This note has been tabled for agreement at the CG-19 meetingon 20 September 2016 (document CG-19-2016-12 AP 13.2). Should the CG meeting result in any changes to the current version, a rev1 version will be made available on Circabc.

[2]Label claims may also contribute to a better communication,not necessarily using the same wording used in the product authorisation documents, but in a manner which is meaningful and comprehensible to the user as required by Article 69(2)(g) of the BPR.

[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]E.g. “for rapid cleaning of all types of surfaces”, “for cleaning of all types of surfaces in cleanrooms class A and B”; “skin compatibility dermatologically tested”; “cleanses the skin deep into the pores”.

[5]Except where a cleaning claim isconsidered in the assessment of the application as a relevant“instruction for use” for the pattern of use of the product and its biocidal efficacy.

[6]See document CA-Nov15-Doc.4.2 – Final on "Submission of example labels, instructions for use, safety data sheets and models or drafts of the packaging, labelling and leaflets within an application for product authorisation", available at

[7]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.).

[8]Not only of the BPR itself but also according to other applicable EU or national legislation in terms of communication of misleading information.

[9]PAR templates are available at ECHA website both for national and Union authorisation procedures.

[10]See principle of "useful effect" referred to in document CA-Sept16-Doc.4.2 on "Mutual recognition of uses meeting the conditions in Article 19 of the BPR but not authorised by the reference Member State".

[11]In any case, until PAR and SPC dissemination is properly implemented by ECHA, these two documents are available to the national competent authorities (CA) for the implementation of the BPR in R4BP. It would then be a task for each CA to coordinate at MS level with the enforcement authorities which label claims are acceptable.

[12]E.g. see the "Claims Matrices" for disinfectants(available at), supporting the "Transitional Guidance on Efficacy assessment of Disinfectants PT1-5" until "Guidance on Efficacy Assessment for Product Types 1-4, Disinfectants", available in "Volume II Efficacy Assessment and Evaluation (Parts B+C)" is published.

[13]See document CA-Sept14-Doc.5.4 – Final, available at