Member States should submit a risk assessment for every notification but in certain cases, the Commission may validate notifications that are submitted without a detailed and individual risk assessment:
The risk level of a product may be considered to be serious if it contains a chemical substance either banned or in a concentration above the limit established by European legislation. Therefore, in cases where measures are taken against products containing a chemical substance subject to a restriction contained in EU Legislation, a notification may be submitted without a detailed risk assessment.
Validation of notifications that do not include a detailed risk assessment may equally be possible for cosmetic products containing banned or restricted substances, which are backed up by an EU scientific committee opinion supporting that such presence of substances above the established limits poses a risk to the health and safety of consumers. For this specific product sector, other factors (e.g. concentration or time of exposure) may need to be taken into consideration.
Nevertheless, if measures have been taken against a product containing not authorised chemical substances for which no scientific opinion has been issued confirming that the product poses a risk, a proper risk assessment may be required depending on a case-by-case analysis to prove that the product poses a serious or less than serious risk. In cases where the risk assessment is needed, if such risk assessment is not provided, these cases shall only be validated ‘for information’ in RAPEX.
As regards products that are subject to restrictive measures by market surveillance authorities based on the presence of a chemical substance mentioned in the list of ingredients which is subject to restrictions contained in EU Legislation and where there is no scientific data assessing the risk, notifications need to be assessed on a case-by-case basis. In case where the risk assessment is needed, if such risk assessment is not provided, these cases shall only be validated ‘for information’ in RAPEX.
Where there is well-documented evidence that certain features of certain products consistently lead to a specific risk and risk level (e.g., the presence of any drawstrings or functional cords in the head, neck or upper chest on garments intended for young children always implies a serious risk), no further risk assessment is required for that given product.