The use of hand cleaning products and hand sanitizers (gels, wipes or other
products that are not rinsed off after use), due to the coronavirus pandemic COVD-19, has increased dramatically in recent weeks, resulting in shortages in most EU countries.
The above products are classified into two categories:
A) Products that are marketed primarily or exclusively for use as cosmetics (i.e. for cleansing the skin, in particular without rinsing with water) and are covered by the Cosmetics Regulation (EC) No. 1223/2009 and which, before being placed on the Greek market, must be notified to the European Cosmetics Portal / CPNP.
Due to the increase in submissions to the Cosmetics Notification Portal under the Cosmetics Regulation (Article 13), as well as related questions on the applicable legislation, the European Commission has issued guidance for economic operators on the applicable legislation and related requirements on the following website:
//ec.europa.eu/docsroom/documents/40523
B) Products containing an active substance and marketed with the main purpose of being used as biocides (i.e. to combat harmful organisms) and, therefore, fall within the scope of the legislation on biocides and Regulation (EU) 528/2012 and for the circulation of which a marketing authorisation from the Hellenic Food and Drug Administration (EOF) is required.
Examples include products containing an active ingredient that make claims that they improve public health by fighting infectious organisms, such as “disinfecting,” “killing viruses,” or “killing bacteria.” These products go beyond the general concept of personal hygiene and can include antibacterial hand gels.
It is recalled that the Hellenic Pharmaceutical Authority issued a relevant announcement on 24-3-20 regarding the procedure for issuing a biocidal product permit by derogation in accordance with article 55(1) of Reg. 528/2012:
BIOKTONA_IMPLEMENTATION_OF_ARTICLE_55
Regarding the Production License for antiseptics to treat the COVID-19 coronavirus
According to article 5 of Law No. 4681/2020 (Government Gazette 74/A/2020), the provisions of case d' of paragraph 6 and paragraph 1 of article 2 of Law 3/1316 (A' 1983) are suspended for 3 months exclusively for enterprises that already hold a license to produce pharmaceutical or cosmetic products, and only with regard to the production of type 1 disinfectant products for human use, either in liquid or gel form or impregnated wipes, the placing on the market and use of which is governed by Regulation EU 528/2012 of the European Parliament and of the Council.
The above companies may produce the above products exclusively for distribution in the Greek Territory and are obliged to comply with all safety rules for the products produced and to inform the public regarding their use and characteristics.
The obligation to exclusively distribute and circulate the products of this paragraph in the Greek Territory and the prohibition on exporting these products outside the Greek Territory applies to both their producers and resellers.
The President of EOF
Dimitrios Filippou
To download the announcement click here
