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 part 1 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 a biocidal product on the German market during the transitional period you have to
- notify it according to German Biocide Notification Ordinance
- notify it to BfR (Bundesinstitut für Risikobewertung) for the poison information database
- classify, label, package it in an appropriate way
- advertise it correctly
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.
Biocidal products where 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 Notification Ordinance
Prior to marketing a biocidal product in Germany during the transitional period, you have to notify it according to the German Biocide Notification Ordinance (Verordnung über die Meldung von Biozidprodukten nach dem Chemikaliengesetz – ChemBiozidMeldeV) under www.biozid-meldeverordnung.de. The notification number (N-XXXXX) must be applied to the product before being marketed in Germany. This notification is free of charge.
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
According to § 16 (e) of ChemG anyone who, in his capacity as the manufacturer or importer or who is using his own trade name, places a biocidal product on the market must submit the following details 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.
The forms for the notification of dangerous preparations/biocides can be downloaded from 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.
It is currently not necessary to provide a confirmation of the active substance supplier for notified biocidal products during the transitional period in Germany at BAuA. However, for biocidal products during the transitional period, compliance with Article 95 will be controlled by the local enforcement authorities. On request, you then will have to provide the corresponding information to the local enforcement authorities.