EU Certification New Regulations: Masks And Other Protective Products In Addition To CE Certification, Must Also Meet This Certification!
It is learned that the latest data of Holland news BNO news network, which has been tracking the diagnosis data of the new global crown pneumonia, has reached 10 points and 03 points by April 23, 2020. The total number of confirmed cases of new crown pneumonia has exceeded 2 million 470 thousand, reaching 2479498 cases, and the cumulative number of deaths has exceeded 170 thousand, reaching 170322 cases.
The US situation is more serious and is not optimistic. Data show that up to now, the cumulative number of confirmed cases in the United States Already exceeded 790 thousand cases, up to 790480 cases, died. Already exceeded 40 thousand cases were as high as 42214 cases.
Up to now, over 41 countries have entered a state of emergency.
Countries declared to be in a state of emergency include:
Italy, Czech, Spain, Hungary, Portugal, Slovakia, Austria, Romania, Luxemburg, Bulgaria, Latvia, Estonia, Poland, Bosnia and Herzegovina, Serbia, Switzerland, Armenia, Armenia, Lebanon, Jordan, Armenia, Palestine, Israel, Costa Rica, Czech, USA , Argentina, Poland, Peru, Panama, Columbia, Venezuela, Guatemala, Australia, Sultan, Namibia, South Africa, Libya, Zimbabwe, Swaziland
According to Mike's foreign trade, it was learned that in the face of the new crown epidemic situation, To meet the growing demand for masks, protective clothing and other anti epidemic products, the EU has opened a green channel without the need for CE logo to enter the European Union for medical workers. Part of the epidemic prevention materials (such as a class of sterilized medical masks) can be marketed in the EU market even if they are not yet certified by CE.
In March 17th, the US FDA opened a similar green channel for new crown virus detection products, allowing test kits to enter the clinical market before EUA has been authorized. At present, many domestic companies, including the Chinese gene, have launched commercial sales in the US clinical market.
In March 13, 2020, European Union members released the Official Journal of the EuropeanUnion's recommendations on conformity assessment and market surveillance procedures for medical devices and personal protective equipment (PPE) during the epidemic.
Medical devices:
(d) if the market watchdog determines that the product conforms to the basic safety and performance requirements of the medical device, even if its compliance evaluation is not yet completed, the market supervisory authority may allow it to sell within a certain time, and the product must continue to complete its compliance evaluation process.
The competent authorities of the member states can also assess and organize procurement of medical devices without CE marking during the epidemic period, which can only be provided to medical workers and can not be sold in the market. At the same time, spot checks will focus on spot checks of anti epidemic medical devices to prevent unqualified products from causing serious risks.
Personal protective equipment (PPE):
The products involved include disposable and reusable masks, reusable work clothes, gloves and eye patch (mainly for the prevention of virus and harmful substances). A public notice institution with PPE authorization is required for compliance evaluation.
(d) if the product of emergency examination and approval does not adopt the PPE regulations and harmonization standards as other technical requirements for product technical requirements, such as the recommendation requirements of WHO, it is necessary to ensure that the technical requirements adopted are equal to the level of protection of PPE basic health and safety requirements. When announcements are issued to other PPE products that require other technical requirements, the notice authority needs to notify the competent authority and other PPE regulatory notices immediately.
(d) if the market watchdog determines that the product meets the basic health and safety requirements of the PPE regulations, the market supervisory authority may allow it to sell within a certain period of time, even if its compliance evaluation is not completed, and the product must continue to complete its compliance evaluation process.
The competent authorities of the member states can also assess and organize the procurement of PPE products without CE marking during the epidemic period, which can only be provided to medical workers and can not be sold in the market. At the same time, spot checks will focus on spot checks of PPE products to prevent serious risks caused by unqualified products.
That is to say, as long as we are in the process of compliance assessment, we can enter the EU market without the CE logo. Spot checks were conducted by market supervision departments, and problems were found to be punished again.
The key is as follows!!!
(c) member states may purchase safe and effective medical products without CE markings;
Emergency supplies are exclusively for medical staff and can not be circulated in the market.
It is effective only during the epidemic period.
About CE logo
The CE tag is like a giant umbrella, and the following are various European Union directives, which stipulate safety standards for various products, subdivided into different materials and production modes. Since its inception in 1985, it has become a symbol of high quality, high standards and strict enforcement. Goods lacking the logo will not be allowed to enter the EU market.
Today, the CE logo has become a globally recognized quality symbol. The CE logo can prove that the products manufactured or imported to EU member states in conformity with the quality standards meet the requirements of protecting consumers' health, supply chain safety and environmental sustainable development.
According to Mike foreign trade, recently, the European Safety Federation published an article on its official website (now updated to April 22nd), and has launched a "fake" for the current CE certificate of personal protective equipment (PPE). The EU suspected fake CE certificates, and more than 20 "certification bodies" were named! ;
The notice states that protective masks (FFP2 or FFP3), goggles and masks, protective gloves and protective clothing, etc., besides satisfying the current CE certification, must also meet other laws and regulations, such as REACH Regulation.
Conformity assessment procedure for PPE
PPE conformity assessment procedures
Remark: This article is valid for Personal Protective Equipment (PPE), such, Equipment, "", " Etc. The conformity assessment procedures for medical devices (e.g. medical or medical)), the first, the second, the third, the second, the second. REACH is always applicable .
Note: This article applies to personal protective equipment (PPE), such as protective masks (FFP2 or FFP3), protective glasses and masks, protective gloves and clothing. Medical equipment (such as medical or surgical procedures) is different. For those masks, you should seek information from the relevant trade associations or authorities. Manufacturers must also check other regulations applicable to the product at the same time (for example, REACH always applies).
Original notice link:
Https://www.eu-esf.org/covid-19/4569-covid-19-conformity-assessment-procedure-for-ppe
REACH is a European Union regulation which aims to enhance the protection of human health and the environment from the risk of chemicals, while enhancing the competitiveness of the EU's chemical industry. It also reduced the alternative method of hazard assessment to reduce the number of tests on animals. ?
In principle, REACH is suitable for all chemicals. Not only for industrial processes, but also for our daily life, such as cleaning products, paint and clothing, furniture and electrical appliances. As a result, the regulation has an impact on most companies in the European Union.
The EU REACH regulation is the abbreviation of "Registration, Evaluation, Authorisation and Restriction of Chemicals". The regulations on registration, assessment, licensing and restriction of chemicals (REACH regulation) passed the final vote of the Council of the European Union in December 18, 2006 and was formally promulgated. It was fully implemented in June 1, 2007.
REACH has replaced the 40 existing EU laws and regulations, and has become a set of unified management regulations for registration, evaluation, licensing and restriction of chemicals. It has a well-established registration and evaluation system involving about 30 thousand chemicals. All existing or new chemicals that require annual production capacity or import volume to reach or exceed 1 tons should be registered to provide relevant safety information.
REACH involves almost all products except food, medicine and pesticides exported to the European Union. The products are divided into three types: substances, mixtures and articles. There are different requirements for different types of products. Personal protective clothing (PPE), such as protective masks (FFP2 or FFP3), protective glasses and masks, protective gloves and protective clothing, belongs to the category of goods. Sales in the EU market need to meet REACH regulatory requirements.
01. Meet the control requirements of SVHC under the REACH regulations.
SVHC is the English abbreviation for highly concerned substances. Regulations have the following requirements for SVHC:
Notification:
If the content is >0.1% and meet the export volume of >1 ton / year, we need to inform ECHA.
Information transmission:
SVHC content of >0.1%, <1 tons / year export volume, it is necessary to transmit the information in the supply chain. If the content is <0.1%, the enterprise does not need to do any operation.
02. Meeting the control requirements of the restricted substances list (Annex XVII) under the REACH regulations:
The list specifies the maximum exemption or usage of all consumer goods entering the EU when using substances in the list. (common o-benzene, azo, organotin, heavy metals, benzene and other substances are listed in it).
Matter (Substance): chemical elements and their compounds obtained in the natural state (existing) or through the production process.
Preparation: mixture or solution consisting of two or more than two substances.
Object (Article): an object consisting of one or more substances and / or one or more preparations. Having a specific shape, appearance, or design scheme.
1. high attention list of substances - SVHC
SVHC is the English abbreviation of "Substance of Very High Concern" (highly concerned substances). It refers to substances that cause great concern to human beings and the environment.
According to the 57 regulation of REACH, substances with high or more concern will be added to the list of SVHC:
1) first types, second types of carcinogenesis, teratogenicity, and reproductive toxic substances, that is, CMR1/2 substances.
2) persistent, bioaccumulative and toxic substances, that is, substance PBT;
3) high persistence, high bioaccumulation substance, vPvB substance.
4) endocrine disrupting characteristics, or persistence, bioaccumulation and toxicity, or high persistence, high bioaccumulation, but not in accordance with the standards of 2 and 3 two.
With the implementation of REACH, ECHA (EU chemicals authority) has published more than one batch of SVHC lists. As of January 16, 2020, the SVHC list was updated to the twenty-second batch, with a total of 205 substances. Enterprises need continuous attention.
2. list of restricted substances - RSL
The list of restricted substances, the annex XVII of the REACH code, limits the manufacture, marketing and use of certain hazardous substances, products and articles, and is an important obligation of goods other than SVHC.
The authorized substances belonging to annex XIV of the REACH code, when the existing economic and technological means have been able to control the risk comprehensively, substitute substances or alternative technologies can completely replace the authorized substances and their uses. ECHA will join the list of restrictive substances in the annex XVII of the REACH regulations and stipulate the maximum exemption amount, limiting its production or import in the European Union.
In line with REACH regulations, personal protective equipment (PPE) is involved in testing items.
1. Highly concerned substance SVHC - all products are applicable.
2. Limiting substances RSL: cadmium, six valence chromium, arsenic, lead, formaldehyde, three acridyl phosphine oxide, polybrominated biphenyl, azo, nonylphenol (polyoxyethylene ether), polycyclic aromatic hydrocarbons, o-phenyl two formate, fumaric acid two methyl ester, two methyl formamide and so on. The testing items are determined by the material and purpose of the product.
Chemicals, alloys, plastic products, semi-finished products and accessories
Toys, furniture, cosmetics, stationery, paints, paints, glue and cleaners.
Textile, clothing, footwear, leather products and accessories
Electrical and electronic products and other products.
Household products, leisure and sporting goods, etc.
1: certification consultation - provide product related information.
2: certification quotation - Assessment of inspection fees and time.
3: fill in the application form, return the contract and sample express.
4: the laboratory carries on the REACH examination to the sample.
5: after testing, issue REACH report.
6:REACH certification report, invoice and other delivery services.
Non EU manufacturers / suppliers provide information on the manufacturing process of UVCB substances.
Links:
Https://echa.europa.eu/documents/10162/21332507/form_manufacturing_process_description_en.pdf/65978750-55b4-14b8-13b3-590786832c2f
The member states or the European Chemicals authority (ECHA) may, at the request of the European Commission, prepare the volumes to be identified as SVHC according to the requirements of appendix XV of REACH. More details of the SVHC identification process can be found under the rule tab.
Prepare and submit SVHC files
Member states can submit SVHC proposals through CIRCABC. There are two submission windows for Annex XV SVHC files each year. The date of submission of annex XV SVHC file before 2020 is confirmed.
February 3, 2020
August 3, 2020
Guidelines for preparing appendix XV files for identifying highly concerned substances :
Https://echa.europa.eu/documents/10162/23036412/svhc_en.pdf/8faef33c-b46e-4186-8b7c-8cfbeccd0812
The list of the high attention substances SVHC list is 205.
Https://echa.europa.eu/candidate-list-table
Guidelines for material identification and naming based on REACH and CLP:
Https://echa.europa.eu/documents/10162/23036412/substance_id_en.pdf/ee696bad-49f6-4fec-b8b7-2c3706113c7d
PBT and vPvB assessments:
Https://echa.europa.eu/documents/10162/13632/information_requirements_r11_en.pdf/a8cce23f-a65a-46d2-ac68-92fee1f9e54f
How to report (Q) SARs:
Https://echa.europa.eu/documents/10162/13655/pg_report_qsars_en.pdf/407dff11-aa4a-4eef-a1ce-9300f8460099
Fifteen SVHC report template:
Https://echa.europa.eu/documents/10162/13638/annex_xv_svhc_report_template_en.doc/906b4cd5-383e-4e68-b0d1-7fd5c7dd6e20
ECHA processes the SVHC recognition program:
Https://echa.europa.eu/documents/10162/13632/procedure_identification_of_svhc_en.pdf/ca7b792f-1fb5-52d4-3db0-fe774db88722
According to Mike's foreign trade, The authorization process aims to ensure that hazardous substances or technologies are gradually replaced by highly hazardous substances (SVHC) in a technically and economically viable alternative.
When the European Commission asked member states or ECHA to identify certain substances as SVHC, the authorization channel began.
Substances with the following dangerous characteristics can be identified as SVHC:
Substances classified according to CLP regulations are classified as 1A or 1B carcinogenic, mutagenic or toxic reproductive (CMR) classification standards.
According to appendix XIII of REACH, substances with persistence, bioaccumulation and toxicity (PBT) or very persistent and highly bioaccumulative substances (vPvB).
The substances depending on the situation are of equal concern with CMR or PBT / vPvBB substances.
Links: Https://echa.europa.eu/documents/10162/13637/afa_applicants_checklist_en.pdf/70190e64-dead-49ce-1d10-a9016d48b74f
Annex: list of EU Member States (27 countries):
Austria, Belgium, Bulgaria, Cyprus, Czech, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Romania, Lithuania, Luxemburg, Malta, Malta, Malta, Portugal, Belgium, Spain, Sweden
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