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In addition to CE certification, respirators and other prot

Recently, the European safety Federation published an article on its official website about some current personal protective equipment (PPE) At the same time of "cracking down on counterfeit" of CE certificate, it also indicates that personal protective equipment (PPE) such as protective mask (FFP2 or ffp3 type), protective glasses and masks, protective gloves and protective clothing must meet the current focus of CE certification as well as reach regulations.

Next, we will comprehensively interpret the responsibilities and obligations of respirators and other protective products under the reach regulation framework, so as to help enterprises respond quickly and comply comprehensively.


conformity assessment procedure for PPE 


remark : this article is valid for Personal Protective Equipment (PPE), such as protective masks (type FFP2 or FFP3), protective glasses and face shields, protective gloves and garments, etc. The conformity assessment procedures for medical devices (e.g. medical or surgical masks) are different and for those you should seek information from the relevant trade associations or authorities. The manufacturer must also check of other legislation is simultaneously applicable to the product (e.g. REACH is always applicable).


be careful! Medical or surgical masks also need to meet REACH regulations.

The original link is as follows:



A CE certificate is not fully understood yet another REACH rule? Let's see what reach is.

REACH Introduction to regulations
The EU REACH regulation is“Registration, Evaluation, Authorisation and Restriction of Chemicals”The abbreviation of is a regulation of EU on chemical registration, evaluation, authorization and restriction, a regulation of EU on preventive management of all consumer goods entering its market, a basic clause of EU on environmental protection requirements for consumer goods, a general clause, and a passport for export to EU.
The regulation came into force on June 1, 2007 and came into effect on June 1, 2008. Reach law replaces more than 40 chemical management laws and regulations of the European Union, and becomes a complete law for unified preventive management of all chemicals entering the European Union market. Personal protective equipment (PPE), such as respirators (FFP2 or ffp3), safety glasses and masks, protective gloves and protective clothing, etc., are sold in the EU market to meet the requirements of REACH regulations.


How can personal protective equipment such as masks meet REACH regulations?

Reach divides products into three types: substance, mixture and article, with different requirements for different types of products.

Personal protective equipment (PPE) such as respirators (FFP2 or ffp3), goggles and masks, protective gloves and protective clothing belong to this category.
The following two points need to be met:


Meet the control requirements of SVHC under REACH Regulation
SVHC is an English abbreviation for substances of high concern. The regulations have the following requirements for SVHC:


If the content is more than 0.1% and the export volume is more than 1 T / a at the same time, ECHA shall be informed;


Information transfer:

If the content is more than 0.1%, the information of the substance needs to be transferred in the supply chain. If the content is less than 0.1%, the enterprise does not need to do any operation.



Meet the control requirements of restricted substances list (Annex XVII) under REACH Regulation

The list specifies the maximum exemption or use of all consumer goods entering the EU when restricted substances are used in the list.

(common o-benzene, azo, organotin, heavy metal, benzene and other substances are listed in the list)

The reach regulation states that a substance contained in Annex XVII which is subject to restrictions shall not be manufactured, placed on the market or used unless it complies with the restrictions. All products circulating in the EU must meet the restriction requirements of annex XVII of reach regulation. Enterprises need to check and test the products, abide by the restriction conditions, and ensure the smooth trade with Europe.

Personal protective equipment (PPE) is defined as an "article" by law.

List of toxic and hazardous substances under REACH Regulation
1.List of substances of high concern*——SVHC
SVHC It is the English abbreviation of "substance of very high concern". It refers to the substance that causes high concern for human and environment risks. With the implementation progress of reach, ECHA (European chemical administration) has successively released a list of SVHC batches. As of January 16, 2020, the list of SVHC has been updated to the 22nd batch, with 205 substances in total. Enterprises need to continue to pay attention to it.
2.Restricted substances list*——RSL
The list of restricted substances, namely annex XVII of reach regulation, restricts the manufacture, marketing and use of certain hazardous substances, preparations and articles, which is an important obligation of articles except SVHC. As an authorized substance in Annex XIV of reach regulation, when the existing economic and technological means have been able to fully control the risk and the substitute substance or technology can completely replace the authorized substance and its use, ECHA will add it to the list of restricted substances in Annex XVII of reach regulation and stipulate its maximum exemption quantity, so as to restrict its production or import in the EU.
Test items involved in personal protective equipment (PPE) to comply with REACH regulations
①High concern substance SVHC - applicable to all products.
②Restricted substances RSL: cadmium, hexavalent chromium, arsenic, lead, formaldehyde, triaacridine phosphorus oxide, polybrominated biphenyls, azo, nonylphenol (polyoxyethylene ether), polycyclic aromatic hydrocarbons, phthalates, dimethyl fumarate, dimethylformamide, etc. The test items are determined by the product material and use.

SVHC is an English abbreviation for substances of high concern. The regulations have the following requirements for SVHC: