Recently, European Safety Federation has published an article on its official website regarding "counterfeiting" CE certificate of some current personal protective equipment (PPE). The article made it clear that protective masks (type FFP2 or FFP3), protective glasses and face shields, protective gloves and garments, etc., should meet the requirements of REACH Regulation besides the CE certification.
In the following, C&K Testing will fully interpret the duties and obligations of masks and other protective products under REACH Regulation to help enterprises better comply with the REACH Regulation.
Overview of REACH
REACH is the Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which came into force on 1 June 2007 and applied on 1 June 2008. It becomes a harmonised regulation concerning preventative administration on all chemicals to be placed on the EU market superseding more than 40 directives and regulations for chemical management. REACH is also applicable to protective masks (type FFP2 or FFP3), protective glasses and face shields, protective gloves and garments, etc.
Classifications of Products Regulated by REACH
- Substance: Chemical elements and their compounds in the natural state (existing) or obtained through production processes.
- Preparation: A mixture or solution consisting of two or more substances.
- Article: An article consisting of one or more substances and / or one or more preparations. Articles have specific shapes, appearances or designs.
*Personal Protective Equipment (PPE) is defined as Article
List of Toxic and Harmful Substances under REACH
SVHC,“Substance of Very High Concern”, refers to any substance that has adverse effects on human health and the environment. Strictly speaking, the list of SVHCs serves as a candidate list for List of Substances Subject to Authorisation.
According to Article 57 of the REACH Regulation, substances that have one or more of the following hazardous characteristics that causing high concern will be included to the SVHCs list:
- Substances which are Class 1, Class 2 carcinogenic, teratogenic, reproductively toxic, namely CMR1 / 2 substances;
- Substances which are Persistent, bioaccumulative and toxic, namely PBT substances;
- Substances which are highly persistent and highly bioaccumulative, namely vPvB substances;
- Substances such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfill the criteria of points 2 or 3-for which there is scientific evidence of probable serious effects to human health or the environment.
With the progress of the implementation of REACH, ECHA (European Chemicals Agency) has successively published a multi-batch SVHC list. As of January 16, 2020, the SVHC list has been updated to the 22nd batch, with a total of 205 substances.
Duties and Obligations of Masks and Other Protective Products under REACH
- Any producer or importer of articles shall submit a registration to ECHA for any substance contained in those articles, if both the following conditions are met: (a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; (b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.
- If the substance is not intended to be released under normal or reasonably foreseeable conditions of use, refer to the following:
2) Any supplier of an article contains SVHCs in a concentration of over 0,1% (w/w) and present in quantities less than one tonne per year shall notify downstream users and pass on the information with relevant certifications;
3) Any supplier of an article contains SVHCs in a concentration of over 0,1% (w/w) and present in quantities over one tonne per year shall notify the information to ECHA;
4) On request by a consumer, any supplier of such articles shall provide the consumer with sufficient information, available to the supplier, within 45 days of receipt of the request, to allow safe use of the article including, as a minimum, the name of that substance.
Restricted substances are in the Annex XVII (also known as Restrictions on the Manufacture, Placing on the Market and Use of Certain Dangerous Substances, Preparations and Articles) to REACH. Any substance on their own, in a preparation or in an article should be restricted on a Community-wide basis when its use poses unacceptable risk to human health and the environment. You may refer to Annex XVII for specific thresholds and scope of restrictions.
If needed, please contact us to get the latest SVHC High Concern Substance List and REACH Annex XVII Restricted Substance List.
Test items for Personal Protective Equipment (PPE)
① Substance of Very High Concern SVHC: All articles are required;
②Restricted substances RSL: cadmium, hexavalent chromium, arsenic, lead, formaldehyde, triacridyl phosphorus oxide, polybrominated biphenyls, azo, nonylphenol (polyoxyethylene ether), polycyclic aromatic hydrocarbons, phthalates, rich Dimethyl maleate, dimethyl formamide, etc.-the testing items is determined by the products’materials and usage.