Transitional measures for biocidal products containing "existing active substances" in Germany
According to Article 17 of Regulation (EU) No. 528/2012 (BPR) biocidal products shall not be made available on the market or used unless authorised in accordance with BPR. However, according to Article 89 of BPR in conjunction with § 28 (8) of the Chemicals Act ("Chemikaliengesetz", ChemG), biocidal products which solely contain active substances listed in Annex II of Regulation (EU) No. 1062/2014 (“existing active substances”) for the relevant product type may be placed on the German market and used without being authorised as long as no decision on approval or non-approval of the respective active substances has been taken.
This also applies for biocidal products generating existing active substances.
For placing biocidal products on the German market during the transitional period they have to
- be notified according to German Biocide Law Implementation Ordinance (ChemBiozidDV)
- be classified, labelled, packaged and advertised in an appropriate way
- comply with article 95 of the BPR
- show the efficacy that is claimed in the product description, the instructions for use or the advertisement
- have to be notified to BfR (Bundesinstitut für Risikobewertung) for the poison information database, if the biocidal product fulfils the general criteria laid down in Article 45 of the CLP regulation (Regulation (EC) No. 1272/2008), i.e. the biocidal product is a mixture, that is classified as hazardous on the basis of its health or physical effects. For further information please refer to the bullet point “Notification for the poison information database”
If a decision on approval has been taken for the active substance, biocidal products which contain this existing active substance are marketable without authorisation until the date of approval of this active substance. In order to preserve the marketability of biocidal products in Germany, according to Article 89 (3) of BPR, an application for authorisation or mutual recognition in parallel has to be submitted to the Federal Office for Chemicals for the respective product type(s) until the date of approval of the active substance. If a biocidal product contains several existing active substances, the application for authorisation or mutual recognition in parallel has to be submitted until the date of approval of the last active substance.
Since the 01.01.2022, products for which an application for authorisation has been submitted are included in the notification procedure. Therefore, since this date, the date of the application for authorisation, and the corresponding case number must also be stated when notifying the corresponding products.
Biocidal products for which applications for authorisation or mutual recognition in parallel have not been submitted in time may only be placed on the German market for 180 days after the date of approval of the active substance and may be used for 365 days after the date of approval.
If a decision on non-approval has been adopted for the active substance, biocidal products which contain this existing active substance may only be marketed and used for another year (unless anything else is stated in the non-approval decision) after the date of publication of the decision not to approve this active substance.
Notification according to German Biocide Law Implementation Ordinance (ChemBiozidDV)
Prior to marketing a biocidal product in Germany during the transitional period, you have to notify it according to the “Ordinance on the Notification and Dispensing of Biocidal Products and on the Implementation of Regulation (EU) No 528/2012” (Biocide Law Implementation Ordinance) - ChemBiozidDV. An online notification form (only in German) is available and free of charge. The notification number (N-XXXXX) must be applied to the product before being marketed in Germany.
According to § 4 of the ChemBiozidDV, the following information must be provided when notifying a biocidal product
- Trade name of the biocidal product
- Name, address and e-mail address of the notifier and, if different, name, address and e-mail address of the manufacturer
- Product type(s) to which the biocidal product is assigned
- Name of the active substances contained in the biocidal product (including active substance concentration and CAS and EC number, if available)
- Date of application for authorisation and corresponding case number, if such an application has been submitted
- Indication of who is acting as substance supplier of the active substance or product supplier of the biocidal product in accordance with Article 95 (see explanations below).
- Confirmation that the biocidal product has the claimed efficacy
The data concerning Article 95 are not made publicly available. Notifications must be updated according to ChemBiozidDV and must be confirmed at least every two years.
Further information on the ChemBiozidDV can be found here: Biocide Law Implementation Ordinance
For the notification of precursors (for the in situ generation of active substances) you will have to select the in situ generated active substance (for example Active Chlorine generated from sodium chloride by electrolysis) as the active substance.
Please note: The Federal Office for Chemicals of the Federal Institute for Occupational Safety and Health (BAuA) is responsible for the notification procedure under transitional measures (prior to placing on the market), as well as for the notification procedure of quantities of biocidal products made available on the market, both stipulated in the ChemBiozidDV. Please direct questions on the above procedures to ChemBiozidDV@baua.bund.de.
The competence for enforcing the regulated making available of biocidal products lies with the respective federal state authorities responsible for trade monitoring. Questions on this topic can be directed to the respective local competent authority: Authority search at ICSMS
For the notification of precursors (for the in situ generation of active substances) you will have to select the in situ generated active substance (for example Active Chlorine) as the active substance.
Notification for the poison information database
In addition to notification to the Federal Office for Chemicals, anyone who places a biocidal product on the market under their own trade name can also notify it to the Federal Institute for Risk Assessment (BfR) at firstname.lastname@example.org. The legal basis for product notification is Article 45 and Annex VIII of the European CLP Regulation (Regulation (EC) No. 1272/2008), for which the BfR is designated in Section 16e of the Chemicals Act (ChemG).
A notification is only not obligatory:
- If the biocidal product is a mixture that is not classified or is classified exclusively on the basis of one or more of the following hazards: hazards to the environment, explosive substances/mixtures and articles containing explosives or gases under pressure.
- If the biocidal product consists solely of the active substance and accordingly does not constitute a mixture. The classification is irrelevant at this point.
However, in order to ensure competent emergency advice for the product by the poison information centres, a voluntary notification can still be submitted.
The following details must be included in a notification to the Federal Institute for Risk Assessment BfR (Bundesinstitut für Risikobewertung):
- Trade name
- Details on composition
- Instructions on use
- Recommendations about precautionary measures when handling and emergency measures in the event of accidents
Furthermore, the manufacturer or importer must also submit details of any later changes to this information which are relevant when treating health disorders that could be caused by the biocidal products. These details must be notified before the preparation is placed on the market for the first time or when it is changed.
Further information you can find on the website of the BfR.
Please note that this requirement applies to each member of a biocidal product family. This obligation covers also the notification of products which will be notified according Article 17 (6) of BPR as well as products of the biocidal product family where the content of pigments, perfumes and dyes will be varied. It is not sufficient to submit just one notification for the whole family.
Classification, Labelling and Packaging
The EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures, the CLP-Regulation, entered into force on 20th January, 2009. Since 1st December, 2010 the classification, labelling and packaging of substances has to comply with this Regulation. For mixtures, the rules of this Regulation are mandatory from 1st June, 2015; this means that until this date classification, labelling and packaging could either be carried out according to Directive 1999/45/EC (Dangerous Preparations Directive) or according to the CLP-Regulation. Substances, as components of a mixture, however, have to be classified according to both, Directive 67/548/EEC (Dangerous Substances Directive) and Regulation (EC) No. 1272/2008 from 1st December, 2010 until 1st June, 2015.
Article 69 BPR stipulates certain information for the labelling of biocidal products in addition to the general labelling requirements for hazardous substances. This information is also required for biocidal products, which are not classified as dangerous preparations according to Dangerous Preparations Directive.
The label of the biocidal product should clearly and indelibly show the information according to Article 69 (1) subparagraph 2 sentence 1 and Article 69 (2) a), e), h), i), j), k), l) and where applicable n) and o).
In addition, it shall be ensured that labels are not misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy and, in any case, do not mention the indications 'low-risk biocidal product', 'non-toxic', 'harmless', 'natural', 'environmentally friendly', 'animal friendly' or similar indications.
Advertisement must be distinguished from the classification and labelling. According to Article 72 BPR, any advertisement for biocidal products shall, in addition to complying with the CLP-Regulation, include the sentences "Biozidprodukte vorsichtig verwenden. Vor Gebrauch stets Etikett und Produktinformationen lesen." ("Use biocides safely. Always read the labelling and the product information before use."). The sentences shall be clearly distinguishable and legible in relation to the whole advertisement. Advertisers may replace the word ‘biocides’ in the prescribed sentences with a clear reference to the product-type (e.g. disinfectant, wood preservative or similar) being advertised. This only applies to the so-called product-external advertisement, i.e. the design of the packaging is not covered by this rule.
Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy. In any case, the advertising of a biocidal product shall not mention 'low-risk biocidal product', 'non-toxic', 'harmless', 'natural', 'environmentally friendly', 'animal friendly' or any similar indication. Apart from that, the term “advertisement” shall be interpreted in a broad sense; the rules particularly apply to offers of biocidal products in the internet.
Please note that, as of 1 September 2015, biocidal products may only be made available on the market if either the substance supplier or the product supplier is included in the list of active substance suppliers (Article 95 BPR). This also applies for biocidal products that are marketed during the transitional period in Germany.
For biocidal products that can be marketed without authorisation under the transitional measures for existing active substances, currently no confirmation of the active substance supplier/manufacturer has to be submitted to the BAuA. However, since 01.01.2022 a self-declaration of conformity to Article 95 must be submitted when biocidal products are notified. The respective authorities of the federal states are responsible for monitoring Article 95 compliance. Upon request, you must be able to provide the competent authorities, for example, with a confirmation from the market participant named in the notification.
Transitional measures in other EU countries
Other EU countries have their own transitional arrangements. Therefore, contact the helpdesks of the respective countries (contact details). ECHA also provides a PDF file with a collection of links (as of 09/2020) on the linked page, which leads to information pages of the individual EU countries on their transitional measures.
Biocidal products that contain new active substances
Biocidal products that contain new biocidal active substances may only be placed on the market after an authorisation or recognition of a foreign authorisation has been granted. A prerequisite for this is that the biocidal active substances contained in the product have been approved for the corresponding product type.
However, it is possible to apply for a provisional authorisation under special conditions.