Interpretation of the new EU mask REACH and application test

Date：2020/6/8　　Clicks：1479

Recently, the European Security Union posted on its website that it is clear that personal protective equipment (PPE) such as protective masks must meet REACH regulations and other requirements.

The following is a screenshot of EU REACH:

The translation is as follows:

Remarks on PPE conformity assessment procedures: This article applies to personal protective equipment (PPE), such as protective masks (FFP2 or FFP3 type), protective glasses and face masks, protective gloves and clothing. The conformity assessment procedures for medical equipment (such as medical or surgical masks) are different. For those masks, you should seek information from the relevant trade association or authority. The manufacturer must also check other regulations that also apply to the product (for example, REACH always applies).

 

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), and also said that protective masks (FFP2 or FFP3 type), protective glasses and face masks, In addition to the currently focused CE certification, protective gloves and protective clothing must also meet other laws and regulations, such as the REACH Regulation, which is very important.

1. What is the REACH Regulation?

REACH is short for EU Regulation (EC) No. 1907/2006 "Registration, Evaluation, Authorization and Restriction of Chemicals". The regulation was published on December 31, 2006, and came into effect on June 1, 2007. In order to ensure the smooth implementation of this regulation, the European Union has set up a competent agency, the European Chemicals Agency (ECHA), which officially went into operation on June 1, 2008.

2. The classification of its controlled products by REACH regulations:

1. Substance: chemical elements and their compounds obtained in the natural state (existing) or obtained through the production process. 

2. Preparation: A mixture or solution composed of two or more substances.

Article: An object composed of one or more substances and/or one or more preparations. Have a specific shape, appearance or design. Personal protective equipment (PPE) is an "article" as defined by the regulations.

3. Control requirements: 

The REACH Regulation stipulates that a substance contained in Annex XVII, which is restricted in 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. In order to comply with REACH regulations, the testing items involved in personal protective equipment (PPE):

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

②Restricted substances RSL: cadmium, hexavalent chromium, arsenic, lead, formaldehyde, etc. The testing items are determined by product materials and uses.

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.

4. REACH certification process for masks/goggles/face masks/gloves/protective clothing:

1. Fill in the application form

2. Provide product information

3. Test
4. Report/Certificate
5. Test cycle 4-5 working days