Regulation (EU) No. 528/2012 (biocide regulation)
 Regulation (EU) No. 528/2012 |
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|---|---|
| Title: | Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 on the making available on the market and the use of biocidal products |
| Designation: (not official) |
Biocide Regulation |
| Scope: | EEA |
| Legal matter: | Environmental law , chemicals law |
| Basis: | TFEU , in particular Article 114 |
| Procedure overview: |
European Commission European Parliament IPEX Wiki |
| To be used from: | September 1st 2013 |
| Reference: | OJ L 167 of June 27, 2012, pp. 1–123 |
| Full text |
Consolidated version (not official) basic version |
| Regulation has entered into force and is applicable. | |
| Please note the information on the current version of legal acts of the European Union ! | |
The Regulation (EU) no. 528/2012 , also known as biocidal regulation is a regulation that the manufacture, labeling, marketing and use of biocidal products that serve regulates to humans, animals, materials or products from harmful Protect organisms such as parasites or bacteria . The proposal was adopted by the European Parliament and the Council in Brussels on May 22, 2012 and entered into force on July 17, 2012.
According to the EU, the purpose according to Paragraph (3) of the regulation to improve the free movement of biocidal products within the Union and at the same time to ensure a high level of protection for human and animal health and for the environment. Approval must be applied for in future for all biocidal products, even if these products have been in use for decades. For a simplified admission, acc. Art 25 in connection with Annex I only 19 simple chemicals including. Not even alcohol, hydrogen peroxide or isopropanol are included in Appendix I of the list. Since a complex approval is required, pharmacists will no longer be able to mix biocidal products in the future, even if they are simple substances with long-known recipes.
Because the demand for disinfectants for hand disinfection is increasing in Germany as a result of the COVID-19 pandemic , and the corresponding preparations were meanwhile practically no longer available in pharmacies and drugstores, the Federal Office for Chemicals announced on March 4, 2020 as the competent authority after consultation with the Federal Ministry for the environment, nature conservation and nuclear safety, the general decree on the approval of biocidal products containing 2-propanol for hygienic hand disinfection in accordance with Article 55 (1) of Regulation (EU) No. 528/2012 is known. This general decree expires on August 31, 2020, as Art. 89 of the EU Regulation only allows exceptions for 100 days.
Web links
- Regulation (EU) No. 528/2012 of the European Parliament and of the Council of 22 May 2012 on the making available on the market and the use of biocidal products
- Legal texts on the biocide regulation
Individual evidence
- ↑ Regulation (EU) No. 528/2012 on the making available on the market and the use of biocidal products. (PDF) The European Parliament and the Council of the European Union, May 22, 2012, accessed on March 8, 2020 .
- ↑ Federal Institute for Occupational Safety and Health :: General decree on the approval of biocidal products containing 2-propanol for hygienic hand disinfection due to a risk to public health. (PDF) March 4, 2020, accessed on March 8, 2020 .