SPC: Summary of Product Characteristics
The Summary of Product Characteristics (SPC, in Dutch: Samenvatting product karakteristieken) is an integral part of an authorisation decision for applications subject to Biocidal Products Regulation (EU) 528/2012. The Biocidal Products Regulation applies to biocidal products that are based on approved substances.
For authorisations issued under the Regulation, it has been concluded that the SPC is sufficient and that it is no longer desirable to adopt legal conditions for use/instructions (WGGA). This conclusion was made following extensive consultation between the Ctgb, the ministry concerned (Infrastructure and Environment) and the enforcement authorities. The Netherlands would like to remain in line with European policy, also with respect to the SPC.
This means that for biocidal products that are authorised under the Regulation, a WGGA will no longer be issued by the Ctgb; instead a SPC will be adopted in which the authorised use is described. The directions for use as printed by the manufacturer on the label of a biocidal product will no longer contain ‘Legal Conditions for Use’.
A change with respect to the WGGA is that it is no longer obligatory to include the exact instructions for use from the SPC on the packaging. For that matter, Article 69.1 clearly states that authorisation holders must ensure that biocidal products are classified, packaged and labelled in accordance with the approved summary of product characteristics of the biocidal product.
The standard EU template contains the following components:
- Administrative information
- Product composition
- Authorised uses
- Classification and labelling
- Directions for use
The SPC does not contain any confidential information. With respect to the composition of the product, only the active substance and the part of the formula (quantitative/qualitative data on excipients) that is needed for correct use are included in the SPC. In chapter 2, the content of active substance in the product is expressed as % technical active substance.
When submitting an application under the Regulation, the applicant includes a proposal for a draft SPC (in the language/languages required by the Member State. For the Ctgb the required languages are English and Dutch). Submission takes place with the aid of R4BP, the IUCLID Report Generator, which helps applicants to prepare the SPC. If the Ctgb assesses the application, they will make sure that the SPC is correct, readable and not ambiguous. If this is not the case, the SPC will be modified accordingly in consultation with the applicant. It is therefore crucial that the SPC is properly filled in by the applicant.
Harmonised sentences SPC
To promote the use of harmonised terms and sentences in the SPC, two documents are available on the ECHA website. These documents are the results of two ECHA Working Parties held in 2015/2016. These harmonized sentences should be used on the SPC when applicable, modification of the sentences can only be done if the application or situation is such that the harmonized sentences do not apply.
The first document, ‘Frequently used sentences in the SPC and translations’ gives frequently used sentences in the free text sections of the SPC and their translation into all EU languages for PT1-5, 8 and 18. The sentences have been grouped according to the relevant SPC field, the product type, and the type of user.
The second document, ‘SPC AVKs translations’ gives harmonised sentences for PT14 (first renewal). This document provides the translations in all EU languages of the agreed SPC templates for anticoagulant rodenticides for different user categories (general public, professionals and trained professionals). In the CA document (CA-Nov16-Doc.4.1.b - Final - harmonised sentences SPC AVKs.doc) explanation is given how to use the harmonized sentences for PT14 anticoagulants. Please note that in the Netherlands for rodenticides several national specific derogations apply. These derogations are only partly visible in the ‘SPC AVKs translations’ document . For an overview of national specific derogations in NL, see the Evaluation Manual part National framework.
- A single authorisation with multiple product names: under the Regulation, it is possible to request multiple product names with a single authorisation. In that case, there will be only a single SPC that includes all product names.
- An authorisation according to 'the same biocidal product' procedure: if ‘the same biocidal product’ procedure is used to acquire an authorisation under the Biocidal Products Regulation, then the newly authorised product will be given its own SPC.
- Biocidal product family: if a number of similar types of biocidal products are authorised as part of a biocidal product family, then each product within this family will be given its own SPC.
The SPCs will be made public by ECHA in the Register for Biocidal Products (R4BP). Furthermore, the Ctgb authorised products databank will continue to exist. For that matter, legal conditions for use/instructions (WGGAs) will continue to exist for products based on non-included substances (non-approved substances). These authorisations are not subject to the Regulation.