Message 002
Communication from the Commission - TRIS/(2021) 00297
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2021/0042/D
No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.
(MSG: 202100297.EN)
1. MSG 002 IND 2021 0042 D EN 27-01-2021 D NOTIF
2. D
3A. Bundesministerium für Wirtschaft und Energie, Referat E C 2, 11019 Berlin,
Tel.: 0049-30-2014-6392, E-Mail: infonorm@bmwi.bund.de
3B. Bundesministerium für Umwelt, Naturschutz und nukleare Sicherheit
Referat IG II 1, Postfach 12 06 29, 53048 Bonn
Tel.: +49 3018 305 - 2730; Fax: +49 3018 10 305 - 2730
E-Mail: Christian.Meineke@bmu.bund.de
4. 2021/0042/D - C00C
5. Ordinance on the reorganisation of secondary national legislation on biocidal products
6. Biocidal products within the meaning of Regulation (EU) No 528/2012
7. -
8. The Ordinance serves to reorganise and further develop the secondary national regulations on biocidal products. The existing Biocide Notification Ordinance [Biozid-Meldeverordnung] on biocidal products that are subject to the transitional provisions under Article 89 of Regulation (EU) No 528/2012 will be adapted to the current legal status as well as further developed. Additional information, inter alia, on the concentration of the active substance and a simple confirmation of efficacy (§ 4(4)(4a) and (7)) as well as information on the supplier of the active substance in accordance with entry in the list under Article 95 of Regulation (EU) No 528/2012 (§ 4(2)(6)) is required.
Moreover, national regulations on the manner of supply of biocidal products are introduced for the first time. These primarily serve to ensure compliance with the substantive requirements of the authorisations for biocidal products in accordance with Regulation (EU) No 528/2012, in particular the restrictions on supply contained therein. To this end, the self-service supply of certain biocidal products is restricted (§ 10) and a compulsory talk upon supply (§ 11) by expert personnel is introduced. In this talk, the purchaser of the product is to be informed in particular of the intended use, methods for alternative treatment and the necessary precautionary measures (§ 11(2)). This obligation also applies to online and mail order sales in an adapted form (§ 12). With regard to the expertise of the personnel, no new regulations on expertise are created. Instead, existing expertise obligations have been adopted.
The regulations of the previous Biocidal Product Authorisation Ordinance [Biozid-Zulassungsverordnung] will be largely repealed, as it has been superseded by EU harmonisation under Regulation (EU) No 528/2012. However, enforcement of the regulations restricting the authorisation of biocidal products for product-types 15, 17 and 20 (cf. § 14) is to continue. Authorisation of biocidal products containing active substances that meet the exclusion criteria under Regulation (EU) No 528/2012 is restricted to trained professional users (§ 15). Furthermore, an obligation to notify the quantity of biocidal products supplied or exported domestically is introduced (§ 16).
9. The provisions on the notification of biocidal products (Section 2) only apply to products that are still marketable in Germany without an authorisation due to the transitional provision in Article 89 of Regulation (EU) No 528/2012. The purpose of the provisions is to provide an overview of the products on the market and to facilitate monitoring. The additional information required is intended to further improve the options for monitoring, also with regard to products that are obviously ineffective. In addition, publication of this information is to increase transparency with regard to the information provided by the supplier of the active substance in accordance with Article 95 of Regulation (EU) No 528/2012.
The regulations on the manner of supply of biocidal products contribute to improving the enforcement of the requirements contained in authorisation decisions under Regulation (EU) No 528/2012. Since the biocidal product authorisation only formally binds the authorisation holder, national regulations are required that also cover the process of supply from the distributor to the consumer. This will ensure that a biocidal product may only be supplied to persons within the authorised user group. The self-service ban on the biocidal products concerned ensures the possibility of verifying whether the purchaser belongs to the authorised user group at the point of sale. The sales talk serves to provide users with improved information on the product on a case-by-case basis, thus contributing to compliance with the risk reduction measures associated with the authorisation. The expertise obligation for supplying personnel has already proven its value in comparable areas (the supply of hazardous chemicals, Chemicals Prohibition Ordinance; the supply of plant protection products). The expertise of the person supplying the product serves as the prerequisite for purchasers being properly informed about the properties of the biocidal product.
Prohibiting the authorisation of certain types of biocidal products makes use of the power granted in Article 37(4) of Regulation (EU) No 528/2012 to refuse authorisation in general for the products referred to therein.
The obligation to notify with regard to biocidal products made available on the market serves to create a basis of data for the targeted design of measures to reduce risks and the development of tailor-made monitoring programmes.
10. Restriction on the placing on the market of a chemical substance, preparation or product
Reference(s) to basic text(s): Act on the protection against hazardous substances [Gesetz zum Schutz vor gefährlichen Stoffen] (Chemicals Act - ChemG)
(https://www.gesetze-im-internet.de/chemg/inhalts_bersicht.html)
Ordinance on the notification of biocidal products pursuant to the Chemicals Act [Verordnung über die Meldung von Biozid-Produkten nach dem Chemikaliengesetz] (Biocide Notification Ordinance - ChemBiozidMeldeV)(http://www.gesetze-im-internet.de/chembiozidmeldev_2011/index.html)
Ordinance on the authorisation of biocidal products and other procedures in chemicals law relating to biocidal products and biocidal active substances [Verordnung über die Zulassung von Biozid-Produkten und sonstige chemikalienrechtliche Verfahren zu Biozid-Produkten und Biozid-Wirkstoffen] (Biocidal Products Authorisation Ordinance - ChemBiozidZulV)
(http://www.gesetze-im-internet.de/chembiozidzulv/)
The basic texts were forwarded with an earlier notification: 2017/56/D: 2011/3/D
11. No
12. -
13. No
14. No
15. p. 14-23 of the draft Ordinance
16. TBT aspect
No - the draft has no significant impact on international trade.
SPS aspect
No - the draft is neither a sanitary nor phytosanitary measure
**********
European Commission
Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu
