ECHA, FDA and other organism together against the COVID-19

ECHA:(European Chemical Agency)

• •In order to increase the manufacture and supply of disinfectants on the European market, the agency is supporting EU / EEA national authorities decision about applying some derogations to the normal authorization of biocidal products requirement.
• •Has made recommendation of specific compositional requirements for two approved active biocides substances, propan-1-ol and propan-2-ol, for their use in disinfectants. These recommendations will allow national authorities to quickly check the new applications quality before deciding on a derogation.
• •To facilitate the work of the authorities and companies seeking information, ECHA has made available a document document with information on:
  • -biocidal active substances approved or revised for use in disinfectant products.
  • -disinfectant products that are affected under the Biocide Regulation (BPR).
  • -disinfectant products authorised under national regimes in Spain, the Netherlands and Switzerland.
• •Regarding administrative processes, ECHA has proposed for cases with a deadline from March to May, such as bill payments, to have a two-month extension. Link for further information.

Enlace a más información.

Some countries have implemented temporary legislative changes in the use and the sale of specific biocides:

• •Switzerland (Federal Office of Public Health, FOPH): has published a General Decree modifying the authorization process for the sale and human use of certain alcohol-based disinfectants. These changes will apply until August 31st, 2020.
• •Sweden (Swedish Chemical Agency, KEMI): has decided to grant an exemption for the disinfectant approval requirements for substances, 1-propanol and 2-propanol. Accepting from now on the manufacture and sale of disinfectants without being necessary to include suppliers in the list of Article 95 of the EU Biocides Regulation (full text). Also accepting exceptions in the language for labelling and SDS for certain disinfectants.
• •France: ha publicado en su Journal Officiel de la République Française an order allowing temporarily the use of hydroalcoholic disinfectant biocides for human hygiene and surface disinfection. These changes will apply until May 31st, 2020.
• •Germany (Federal Institute for Occupational Safety and Health, Baua): has announced a General Decree approving the use of biocidal products containing isopropanol for hand disinfection. In addition, they define two specific formulations that would meet the marketing requirements in the German state. These changes will apply until August 31st, 2020.
• •United Kingdom (HR Revenue & Customs): has published the guide “Producing hand sanitiser and gel for coronavirus (COVID-19)” where is described the temporary changed to the use and supply of denatured alcohol and duty-free spirits, to help businesses who produce hand sanitiser and gel.
• •Similar temporary changes to national legislation are expected across Europe.

FDA: (U.S. Food and Drug administration)

Has published the “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry” about the hand sanitizer manufacture according to the guidelines of the World Health Organization (OMS). In this document, it is mentioned that the administration will not impose any action against companies that, although not approved by the FDA, manufacture hand sanitizers during the COVID-19 outbreak.