Manufacturers and importers of cosmetic products who are responsible for the cosmetic product placed on the market and distributors in Latvia have a duty to notify the Health Inspectorate of the material undesirable effects of the cosmetic product, which have taken place in Latvia and for which they have become aware.
This responsibility for the responsible persons and distributors is laid down in Article 23(1) of Regulation 1223/2009 on cosmetic products:
“In the event of significant adverse effects, the responsible person and distributors shall immediately notify the competent authority of the Member State where significant adverse effects have been identified of the following information:
- any material form of undesirable effects known to them or reasonably believed to be known to them;
- the name of the cosmetic product concerned which allows it to be identified;
- their corrective action, if any. "
For the submission of information, the form set out in Annex 1 to Cabinet Regulation No. 354 of 2 July 2013, Procedures for the Provision of Essential Requirements for Cosmetic Products (hereinafter - Regulation No 354) “Report to the competent authority on significant undesirable effects of cosmetic products” (hereinafter - form) should be used.
Each undesirable effect is not considered to be significant, and therefore the responsible persons and distributors who have received information from a consumer or a doctor must make sure, before communicating the information to the Health Inspectorate, that the seriousness of the impact is in line with that defined in Article 2 of Regulation 1223/2009:
“significant undesirable effects” means undesirable effects resulting in temporary or permanent functional incapacity, disability, hospital care, congenital malformations or immediate life risk, or death;
Consequently, the obligation to notify using a single model form is limited to significant adverse effects.
- When completing the form on a case-by-case basis, the operator shall assign a number to the report. If an additional and/or final report is also prepared for the same case, the same number of the original report shall be indicated;
- The data on the consumer form must be indicated in such a way as to prevent the person from being identified;
- A specific diagnosis may only be indicated on the form if determined by the doctor (accompanied by a documentary approval).
As the responsible person must collect all the information available to the distributor in order to assess whether the occurrence is attributable to the identified cosmetic product used by the consumer. As much information as possible is needed to perform a causation assessment.
The responsible person has an obligation to assess the need for corrective measures proportionate to the nature and frequency of the adverse effects, in order to reduce the likelihood of repeated significant adverse effects.
The responsible person will receive information regarding the material adverse effects of the cosmetic product if the doctor or consumer has notified it to the competent authority in Latvia or another EU Member State.
Detailed information on the management of major adverse effects is available in the European Commission's guidelines on “GUIDELINES FOR REPORTING SIGNIFICANT ADVERSE EFFECTS” and on the European Commission's website http://ec.europa.eu/growth/sectors/cosmetics/market-surveillance/index_en.htm
“SUE Form A” in English, available on the website of the European Commission, is similar to the form in Latvian in Annex 1 to Regulation No 354, and therefore the instructions for completing the “SUE Form A” are also valid for filling out the form. . A single model form is required to indicate in a harmonised manner all relevant aspects of significant adverse effects, since this information is communicated to the competent authorities of the Member States pursuant to Regulation 1223/2009.
It is recalled that the safety report for a cosmetic product should include information on any adverse effects on human health, including those which are not relevant if they are related to the use of the cosmetic product under normal or reasonably foreseeable conditions of use.