HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL
Safety of the food chain
Pesticides and Biocides
Note for Guidance
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: Q&A concerning the content of some SPC sections
Background and purpose of the document
(1) In the context of the discussions concerning the SPC template for a single biocidal product[1] at the 7th meeting of the Coordination Group and at the 57th CA meeting, several MSs raised questions regarding the information to be included in some sections of the SPC.
(2) This note provides a common understanding of the information to be filled in within these SPC sections in a Q&A format. The note is intended to be a living document to which additional Q&A can be added upon discussion and agreement within the Coordination Group.
Questions and answers (Q&A) on information required in the SPC
Section 1. Administrative information
Heading 1.1 – Trade name(s) of the product
(3) Q: Which trade name(s) have to be listed in the SPC of a national authorisation?
A: For a national authorisation this field in the SPC is MS-specific, so it will only include the name(s) authorised in that MS.
Heading 1.2 - Authorisation holder
(4) Q: Is the field “authorisation holder” (AH) in the SPC MS-specific? In a MR procedure, can the prospective AH in a CMS be different of the (prospective) AH in the RefMS?
A: In the context of a MR procedure, an applicant can submit the application to the target CMS(s) on behalf of different prospective AH(s), who can also be different to the (prospective) AH in the RefMS. Once the national authorisation is granted, the AH is MS-specific and the SPC will only include the name of the AH in that MS.
Heading 1.3 – Manufacturer(s) of the product
(5) Q: Can the location of the manufacturing sites be regarded as confidential in accordance with Article 66?
A: No, the location of the manufacturing site(s) for the manufacturer(s) of the biocidal product has to be mentioned in the published SPC.
(6) Q: In case of MR procedures, which manufacturing site(s) of the biocidal product should be listed in the SPC?
A: The draft SPC submitted by the refMS to the CMSs in case of MR in parallel (or the SPC authorised in case of MR in sequence) should list any manufacturers of the product, so this would cover the manufacturers in all the MSs.
(7) Q: Can the prospective AH in a CMS propose a new/different manufacturer within the MR procedure?
A: No, this element is part of the SPC so the authorisation in CMSs shall be subject to the same terms and conditions as in the refMS. Once the CMS has granted the national authorisation, the AH can notify an administrative change in order to add a new manufacturer in that MS, provided that the product composition and the manufacturing process remain unchanged. It has to be noted that this administrative change would not have any impact regarding the renewal procedure in accordance with Regulation 492/2014.
(8) Q: Have sites where filling operations are carried out by contract manufacturers to be listed in the SPC?
A: No. Only sites where the manufacturing processes leading to the final[2] biocidal product take place (except sites that perform filling operations) or, where they are different, those which allocate the production batch numbers referred to in Article 65(2)(d), should be listed in the SPC.
Upon request from a CA, for enforcement purposes for instance, the AH shall without delay provide information on the different sites involved in the whole manufacturing process, including contract manufacturers.
It has to be noted though that contract manufacturers carrying out filling operations are subject to the relevant obligations referred to in Article 65(2) of the BPR and where relevant, to national legislation regarding the registration or authorisation of manufacturers of biocidal products.
Heading 1.4 – Manufacturer(s) of the active substance(s)
(9) Q: Can the location of the manufacturing sites be regarded as confidential in accordance with Article 66?
A: No, the location of the manufacturing site(s) for the manufacturer(s) of the active substance(s) has to be mentioned in the published SPC.
Section 2. Product composition and formulation
Heading 2.1 – Qualitative and quantitative information on the composition of the product
(10) Q: Should the content of active substance (AS) be expressed in terms of technical or pure AS? Depending on the way to express this content, it could lead to significant differences in the final product composition and be misleading during MR procedures.
A: Without prejudice of any additional information provided by the PAR[3], where both values can be presented, the table in the SPC should refer to the content in terms of pure AS. Taking into account that detection methods are based on the pure AS, providing this information in the SPC would allow official control laboratories to check the content of the AS mentioned in the label without further investigations on the AS purity.
Where an AS approval covers two isomers, the SPC should express the content of pure AS in terms of the mixture of both isomers; e.g. "4% w/w (mixture of alpha/cis and beta/trans isomers)".
(11) Q: This section of the SPC will provide information on the non-active substances knowledge of which is essential for the proper use of the product only. However, some CAs might wish reflecting the full composition of the product in the authorisation. How can this be handled?
A: Where a CA wishes to refer to the full composition of the product in the authorisation decision, that CA can either cross-refer to the composition as described in the IUCLID file or in the confidential annex to the PAR, or to an ad hoc document which shall then be uploaded on R4BP3 and kept confidential.
(12) Q: Which non-active substances should be considered as those, knowledge of which is essential for the proper use of the product?
A: This should be addressed on a case by case basis according to the outcome of the risk assessment, which may depend on the properties and function of the non-active substances within the biocidal product. Non-active substances considered as substances of concern should be listed in all cases.
Section 3. Hazard and precautionary statements
(13) Q: Should the "EUH statements" referred to in the CLP Regulation be considered as "hazard statements" and therefore be listed in the SPC?
A: The wording "hazard statements" laid down in Article 22(2)(j) should be interpreted broadly to encompass also "supplementary hazard statements" such as the EUH statements, in order to give useful effect to the provision coherently with the aim of the BPR to protect human health.
(14) Q: According to Article 28(3) of the CLP Regulation, in principle not more than six precautionary statements shall appear on the label. However, how many P-statements should be listed in the SPC?
A: Article 22(2)(i) of the BPR refers to "precautionary statements" in general, so this means that any P-statements triggered by the CLP legislation should be listed in the SPC. However, in accordance with paragraph 8 of document CA-May13-Doc.5.4[4], a P-statement that has been proven unnecessary in the risk assessment because of the intended use of the product should be left out of the SPC (and of the label).
(15) Q: Who is responsible for the choice of the six P-statements appearing on the label among those listed in the SPC? Is the CA or the authorisation holder?
A: According to Article 69(1) of the BPR, authorisation holders are responsible to ensure that biocidal products are labelled in accordance with the approved SPC and the CLP legislation. According to Article 22(3) of the CLP Regulation, the labelling of the products will only include the P statements which are relevant for the intended uses of the products (e.g. where the product label does not cover all the authorised uses in the SPC).
(16) Q: If the risk assessment triggers risk mitigation measures (RMMs) that are listed in the CLP regulation as P-statements, should these P-statements be listed under the section 3, even if these phrases are not triggered by the criteria in the CLP Regulation?
A: No, section 3 should only contain P-statements which are triggered by the criteria in the CLP Regulation (unless they are irrelevant as a result of the risk assessment – see Q&A 12 above). RMMs resulting from the risk assessment should be referred to under heading 4.1.2, where they are use-specific, or under heading 5.2 where they are applicable to any of the authorised uses.
Section 4. Authorised uses
Heading 4.1 – Use description
(17) Q: What information should be provided under the "name of the use" field?
A: This field should provide a short or synoptic description of the authorised use, which is further detailed in the associated table below the name of the use. See some examples below for different PTs:
For PT 14: Mice – non-professionals – indoor; Rats – professional users – sewers – large blocks,
For PT 8: Wood staining fungi – professional users – spraying – outdoor,
For PT 19: Repellent – (adult) mosquitos – general public (above 12 years) – spraying – outdoor.
The terms chosen for the description of the authorised use should facilitate the comprehension by final users and inspectors[5].
(18) Q: What does the field "where relevant, an exact description of the authorised use" mean within the table describing a use?
A: This field is intended to provide a more specific description of the use for those PTs where different uses are referred to within the PT description in Annex V to the BPR (e.g. repellent or attractant in PT 19; disinfectant of drinking water for humans or for animals in PT 5; insecticide or acaricide in PT 18, etc.). This field would be empty for other PTs (e.g. rodenticides, avicides, piscicides, etc.), so that is why it has to be filled in "where relevant".
(19) Q: Can several combinations for e.g. user categories/target organisms/field of use be presented in the same table? (e.g. for PT18, can both (i) professional and non-professional users, and (ii) flies & mosquitos and (iii) indoor and outdoor be described in the "same use"?) And can there be combinations of different application methods and application rates in the same table/use? (e.g. as for PT8)
A: Yes, a use can be the result of different combinations of these elements provided that they are compatible (i.e. for some PTs, the pack sizes for professional and non-professional users are different). It has to be noted though that in accordance with the principles set by document CA-May14-Doc.5.6[6], the label of the product shall have full correspondence with that authorised use as described in the SPC.
Whenever possible, grouping of different user categories, fields of use should or target organisms[7] within a single use should be considered in order to reduce the size of the SPC.
(20) Q: In the context of a procedure of MR in parallel, can a RefMS include within the use description a target organism for which the biocidal product has been assessed and is effective, but it is not being present in harmful quantities in that MS?
A: Where a target organism cannot be authorised by the RefMS on the grounds referred to in Article 37(1)(e) of the BPR, such target organism should be included in the draft SPC proposed by RefMS (in EN) and be also reflected in the agreed SPC so that CMSs can authorise the product in conformity with it. The specific situation in the refMS should be clearly flagged in the agreed SPC (e.g. by adding a footnote “The target organism (or use) cannot be authorised in RefMS due to …..”). However, for consistency and in order to avoid any misunderstanding by the readers of the final SPC issued by the refMS, section 4 should list the authorised target organisms only.
Section 5. General directions for use
Heading 5.3 – Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
(21) Q: Concerning first aid instructions; What information should be considered for the agreement on the SPC in MR procedures? How should CMSs handle some country-specific information?
A: These elements have been addressed in a specific note for guidance (see document CA-Sept14-Doc.5.6-Final[8]).
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[1] See the SPC template agreed under document CA-Sept14-Doc.5.4–Final, available at https://circabc.europa.eu/w/browse/8aa3692b-9a69-43c7-b30b-d9db9a276830
[2] E.g. adding a rodenticide to a mixture of cereals, but not the mixing of cereals itself.
[3] E.g. detailed description of the identity of the substance as in the active substance approval.