Recently, the European Safety Federation (European Safety Federation) published an article on its official website to "fake" the current CE certificates of some personal protective equipment (PPE). It also said that protective masks (FFP2 or FFP3 type), protective glasses and Personal protective equipment (PPE) such as face masks, protective gloves, and protective clothing must meet the REACH regulations in addition to the currently focused CE certification.

Next, ZRLK comprehensively interprets the responsibilities and obligations of protective products such as masks under the framework of REACH Regulation to help enterprises respond quickly and comply fully.

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).

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

The original link is as follows:

https://www.eu-esf.org/covid-19/4569-covid-19-conformity-assessment-procedure-for-ppe

A CE certificate hasn't fully understood yet another REACH regulation? Below ZRLK will take you to understand what REACH is.

Introduction to REACH Regulation

The EU REACH regulation is "Registration, Evaluation,

Authorisation and Restriction of Chemicals” is an EU abbreviation for the registration, evaluation, authorization and restriction of chemicals in the EU. It is the EU’s preventive management of all consumer products entering its market. It is the EU’s environmental protection requirement for consumer products. The basic terms and general terms are passports for export to the EU.

The regulation came into effect on June 1, 2007 and was officially implemented on June 1, 2008. The REACH regulation replaces more than 40 EU chemical management laws and regulations and becomes a complete regulation for the unified preventive management of all chemicals entering the EU market. Personal protective equipment (PPE), such as protective masks (FFP2 or FFP3 type), protective glasses and face masks, protective gloves and protective clothing, etc., need to meet the REACH regulations in the EU market.

How do personal protective products such as masks meet REACH regulations?

REACH divides products into three types of substances, mixtures and articles, and has different requirements for different types of products.

Personal protective equipment (PPE) such as protective masks (FFP2 or FFP3 type), protective glasses and face masks, protective gloves and protective clothing fall into the category of articles.

The following two points need to be met:

1. Meet the control requirements of the Highly Concerned Substance List (SVHC) under the REACH Regulation

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

Notification:

If the content is >0.1% and at the same time meets the export volume of >1 ton/year, you need to notify ECHA;

Information transfer:

If the content is >0.1%, the information of the substance needs to be transmitted in the supply chain. If the content is less than 0.1%, the enterprise does not need to do anything.

2. Meet the control requirements of the restricted substance list (Annex XVII) under the REACH Regulation

The list stipulates the maximum exemption or use amount of all consumer products entering the EU when using restricted substances in the list

(Common o-benzene, azo, organic tin, heavy metals, benzene and other substances are listed)

The REACH regulation stipulates that a substance contained in Annex XVII, which is restricted, itself, in a preparation or in an article shall not be manufactured, placed on the market or used unless it complies with the restrictions. All products that circulate within the EU must comply with the restrictions of Annex XVII of the REACH Regulation. Enterprises must conduct inspections and tests on the products, observe the restrictions, and ensure smooth trade with Europe.

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

List of toxic and hazardous substances under REACH regulations

1. High Concern Substance List*——SVHC

SVHC is the English abbreviation of "Substance of Very High Concern" (Substance of Very High Concern), which refers to substances that cause high concern for humans and the environment. As the implementation of REACH progresses, ECHA (European Union 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, companies need to continue to pay attention.

2. List of restricted substances*——RSL

The list of restricted substances, that is, Annex XVII of the REACH Regulation, restricts the manufacture, placing on the market, and use of certain hazardous substances, preparations, and articles, and is an important obligation for articles other than SVHC. For the authorized substances belonging to Annex XIV of REACH Regulation, when the existing economic and technological means can already fully control the risks, the alternative substances or alternative technologies can completely replace the authorized substances and their uses, ECHA will add them to the list of restricted substances in Annex XVII of REACH Regulation and stipulate Its maximum exemption limits its production or import within the EU.

In order to comply with the REACH regulations, personal protective equipment (PPE) related testing items

① Substance of high concern SVHC-applicable to all products.

②Restricted substances RSL: cadmium, hexavalent chromium, arsenic, lead, formaldehyde, triacridyl phosphorus oxide, polybrominated biphenyl, azo, nonylphenol (polyoxyethylene ether), polycyclic aromatic hydrocarbons, phthalates, Dimethyl fumarate, dimethylformamide, etc. The testing items are determined by product materials and uses.

During the epidemic, ZRLK testing set up a special testing and certification team for mask products, studying the latest domestic and foreign epidemic emergency measures and policies, and rationally allocating resources to ensure that customers meet the needs of the cycle, and provide domestic GB2626 testing, EU CE certification, and the United States for mask products of various enterprises. EUA registration, REACH testing, ROHS testing and other testing and certification services.