It has been learned that the latest data from the Dutch media BNO News Network, which has been tracking global new coronary pneumonia diagnosis data, as of 10:03 on April 23, 2020, the global cumulative number of new coronary pneumonia confirmed cases has exceeded 2.47 million, reaching 2479498 cases, and the cumulative number of deaths has exceeded 170000, reaching 170322 cases.
Among them, the situation in the United States is more serious, not optimistic, the data show that so far, the cumulative number of confirmed cases in the United States.has exceeded790000 cases, up to 790480 cases, death caseshas exceeded40000 cases, up to 42214 cases;
So far, more than 41 countries have entered a state of emergency.
States that have declared a state of emergency include:
Italy, Czech Republic, Spain, Hungary, Portugal, Slovakia, Austria, Romania, Luxembourg, Bulgaria, Latvia, Estonia, Poland, Bosnia and Herzegovina, Serbia, Switzerland, Armenia, Moldova, Lebanon, Jordan, Kazakhstan, Palestine, Philippines, El Salvador, Costa Rica, Ecuador, United States, Argentina, Poland, Peru, Panama, Colombia, Venezuela, Guatemala, Australia, Sudan, Namibia, South Africa, Libya, Zimbabwe, swaziland
According to Mike Foreign Trade, in the face of the new crown epidemic,In order to meet the growing demand for epidemic prevention supplies such as masks and protective clothing, the EU has opened a green channel that can enter the EU without CE marking for use by medical workers.Allow some epidemic prevention materials (such as a class of sterilized medical masks) to be sold on the EU market, even if they have not yet obtained CE certification, if they are safe and effective.
On March 17, the U.S. FDA opened a similar green channel for new coronavirus testing products, allowing test kits to enter the clinical market before they have been authorized by EUA. At present, a number of domestic companies, including BGI, have started commercial sales of their products in the US clinical market.
On 13 March 2020, the EU Member States published recommendations on conformity evaluation and market surveillance procedures for medical devices and personal protective equipment (PPE) during the outbreak in the Official Journal of the European Union (Official Journal of the EuropeanUnion).
Medical devices:
◆ If the market supervision organization determines that the product meets the basic safety and performance requirements of the medical device, even if its conformity evaluation has not been completed, the market supervision organization may allow it to be sold within a certain period of time, and the product must continue to complete its conformity evaluation process.
The competent authorities of the member states may also evaluate and organize the procurement of medical devices without CE marking during the epidemic. The products can only be provided to medical workers and cannot be sold on the market. At the same time, market spot checks will focus on epidemic prevention-related medical devices to prevent substandard products from causing serious risks.
Personal protective equipment (PPE):
The products involved include disposable and reusable masks, reusable work clothes, gloves and eye masks (mainly products to prevent viruses and harmful substances). A notified body with PPE regulatory authorisation is required to carry out a conformity assessment.
◆ If the emergency approval product does not adopt the PPE regulation coordination standard as the product technical requirements and adopts other technical requirements, such as WHO recommendation requirements, it must ensure that the adopted technical requirements are at the same level of protection as the basic health and safety requirements of the PPE regulation. When a notified body issues such PPE products with other technical requirements, it is necessary to immediately notify the competent authority and the notified body of other PPE regulations.
◆ If the market surveillance agency determines that the product meets the basic health and safety requirements of the PPE regulations, even if its conformity evaluation has not been completed, the market surveillance agency may allow it to be sold for a certain period of time, and the product must continue to complete its conformity evaluation process.
The competent authorities of the Member States may also evaluate and organize the procurement of PPE products without CE marking during the outbreak, which can only be used by medical workers and cannot be distributed on the market. At the same time, market spot checks will focus on epidemic prevention-related PPE products to prevent substandard products from causing serious risks.
In other words, as long as it is in the process of ongoing conformity assessment, it is possible to enter the EU market without CE marking. The market supervision department shall conduct spot checks and punish the problems found.
The focus is as follows!!!
Member States may purchase safe and effective medical products without CE marking;
◆ Emergency materials are exclusively for medical personnel and cannot be circulated in the market;
◆ Valid only during the outbreak.
About CE Marking
The CE label is like a giant umbrella, under which are various EU directives that stipulate various product safety standards, subdivision into different materials and production modes. Since its establishment in 1985, it has become a symbol of high quality, high standards and strict law enforcement. Goods lacking this mark will not be allowed to enter the EU market.
Today, the CE mark has become a globally recognized quality mark. The CE mark can prove that the products produced in the EU or imported into EU member states meet the quality standards and meet the requirements of consumer health protection, supply chain safety and environmental sustainability.
According to Mike's foreign trade, recently, the European Safety Union (European Safety Federation) published an article on its official website (currently updated to April 22) to "fake" the CE certificates of some current personal protective equipment (PPE) "(Emergency announcement! EU anti-counterfeiting suspicious CE certificate, more than 20 "certification bodies" were named!）；
The notice states that protective masks (FFP2 or FFP3 type), protective glasses and masks, protective gloves and protective clothing, etc., in addition to meeting the current focus of CE certification, must also meet other laws and regulations, such as REACH Regulation.
conformity assessment procedure for PPE
PPE Conformity Assessment Procedure
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: 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, etc. conformity assessment procedures for medical devices (e. g. medical or surgical) masks) are different, and 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).
Original announcement link:
https://www.eu-esf.org/covid-19/4569-covid-19-conformity-assessment-procedure-for-ppe
REACH is an EU regulation that aims to improve the protection of human health and the environment from possible risks posed by chemical substances, while enhancing the competitiveness of the EU chemical industry. It also reduces alternative methods of hazard assessment for substances to reduce the number of tests on animals.
In principle, REACH applies to all chemical substances. It is not only used in industrial processes, but also in our daily lives, such as cleaning products, paints, and items such as clothes, furniture and electrical appliances. The regulation therefore has implications for most companies throughout the EU.
欧盟REACH法规 是“Registration, Evaluation, Authorisation and Restriction of Chemicals”的英文缩写，The Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH Regulation) was adopted by the final vote of the Council of the European Union on December 18, 2006, and has been officially promulgated and will be fully implemented on June 1, 2007.
REACH replaces the current 40 EU regulations to become a unified set of regulations for the registration, evaluation, licensing and restriction of chemicals. It has a comprehensive registration and evaluation system covering about 30000 chemical substances. It requires all "existing" or "new" chemical substances with an annual production or import volume of 1 ton or more to be registered to provide relevant use safety information.
REACH covers almost all products (except food, pharmaceuticals, pesticides) exported to the EU,The product is divided into three types of substances, mixtures and articles, and there are different requirements for different types of products. Personal protective equipment (PPE) such as protective masks (FFP2 or FFP3 type), protective glasses and masks, protective gloves and protective clothing belong to the category of articles,Sales in the EU market are required to meet REACH requirements.
01. Meet the control requirements of the list of substances of very high concern (SVHC) under the REACH regulation
SVHC is the English abbreviation of substances of very high concern. The regulations have the following requirements for SVHC:
Notification:
If the content is> 0.1% and the export volume is> 1 ton/year, it needs to be notified to ECHA;
Information transfer:
If the SVHC content is> 0.1% and <1 ton/year, the information of the substance needs to be transmitted in the supply chain. If the content is <0.1%, the enterprise does not need to do anything.
02、To meet the control requirements of the REACH Restricted Substances List (Annex XVII):
The list provides for the maximum exemption or use of the restricted substances in the list for all consumer goods entering the EU.(Common o-benzene, azo, organic tin, heavy metals, benzene and other substances are in its list)
Substance (Substance): Chemical elements and their compounds in their natural state (existing) or obtained through production processes.
Formulation (Preparation): a mixture or solution consisting of two or more substances.
Article (Article): An object consisting of one or more substances and/or one or more preparations. Having a particular shape, appearance, or design.
1. List of Substances of High Concern-SVHC
SVHC is the English abbreviation for "Substance of Very High Concern" (substances of very high concern), which refers to substances that cause risks to humans and the environment and cause high concern.
According to Article 57 of the REACH Regulation, substances that have one or more of the following hazardous properties and are of high concern will be added to the SVHC list:
1) Class 1, Class 2 carcinogenic, teratogenic and reproductive toxic substances, namely CMR1/2 substances;
2) Persistent, bioaccumulative and toxic substances, namely PBT substances;
3) high persistence, high bioaccumulation of substances, namely vPvB substances;
4) Substances with endocrine disrupting properties, or with persistence, bioaccumulation and toxicity, or with high persistence, high bioaccumulation but do not meet the criteria of 2 and 3, and have scientific evidence to prove that they have serious effects on humans or the environment.
With the progress of the implementation of REACH, ECHA (European Union Chemicals Administration) has published a number of batches of SVHC list, as of January 16, 2020 SVHC list updated to the 22nd batch, a total of 205 substances, enterprises need to continue to pay attention.
2. Restricted substances-RSL
The list of restricted substances, Annex XVII of REACH, restricts the manufacture, placing on the market and use of certain dangerous substances, preparations and articles, which is an important obligation of articles other than SVHC.
For authorized substances belonging to Annex XIV of REACH Regulation, when existing economic and technical means can fully control risks and 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 their maximum exemption amount to restrict their production or import within the EU.
In order to comply with REACH regulations, personal protective equipment (PPE) involved in testing items
① Substances of high concern SVHC-applicable to all products.
② Restricted substances RSL: cadmium, hexavalent chromium, arsenic, lead, formaldehyde, triacridinyl phosphorus oxide, polybrominated biphenyls, azo, nonylphenol (polyoxyethylene ether), polycyclic aromatic hydrocarbons, phthalates, dimethyl fumarate, dimethylformamide, etc. The test items are determined by the material and use of the product.
Chemicals, alloys, plastics, semi-finished products, accessories
Toys, furniture, cosmetics, stationery, paint, glue and detergent
Textile and clothing, footwear products, leather products and accessories
Electrical and electronic products and other products
Household goods, leisure and sporting goods and so on
1: certification consulting-to provide product-related information
2: Certification Quote-Evaluation of Testing Costs and Time
3: fill in the application form, return the contract and sample express
4: Laboratory samples for REACH testing
5: After passing the test, issue a REACH report
6:REACH certification report, invoice and other delivery services
Non-EU manufacturers/suppliers provide information on the manufacturing process of UVCB substance.
Link:
https://echa.europa.eu/documents/10162/21332507/form_manufacturing_process_description_en.pdf/65978750-55b4-14b8-13b3-590786832c2f
Member States or the European Chemicals Agency (ECHA) may, at the request of the European Commission, propose substances identified as SVHCs by preparing dossiers in accordance with the requirements of Annex XV of REACH. More details of the SVHC identification process can be found under the "Rules" tab.
Prepare and submit SVHC files
Member States may submit SVHC proposals by CIRCABC. There are two submission windows per year for submission of Annex XV SVHC files. The date for submission of the Annex XV SVHC dossier by 2020 was established:
February 3, 2020
August 3, 2020
Guidance on the preparation of Annex XV dossiers for the identification of substances of very high concern:
https://echa.europa.eu/documents/10162/23036412/svhc_en.pdf/8faef33c-b46e-4186-8b7c-8cfbeccd0812
The latest 205 items in the list of substances of high concern SVHC:
https://echa.europa.eu/candidate-list-table
Guidelines for the identification and naming of substances according to REACH and CLP:
https://echa.europa.eu/documents/10162/23036412/substance_id_en.pdf/ee696bad-49f6-4fec-b8b7-2c3706113c7d
PBT and vPvB assessment:
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 Templates:
https://echa.europa.eu/documents/10162/13638/annex_xv_svhc_report_template_en.doc/906b4cd5-383e-4e68-b0d1-7fd5c7dd6e20
ECHA handles the SVHC identification procedure:
https://echa.europa.eu/documents/10162/13632/procedure_identification_of_svhc_en.pdf/ca7b792f-1fb5-52d4-3db0-fe774db88722
