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Consumer Products | Bimonthly bulletin | May 2021

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Europe

 

ECHA proposes seven substances for authorisation to be included in Annex XIV

 

ECHA recommends that the European Commission add the following seven substances to the Authorisation list.

 

Substance name

Hazardous properties

Examples of uses in the scope of authorization

Octamethylcyclotetrasiloxane (D4)

PBT, vPvB

Electronic articles production, non-metal surface treatment

Decamethylcyclopentasiloxane (D5)

Electronic articles production, dry cleaning, scar and wound treatment

Dodecamethylcyclohexasiloxane (D6)

Formulation of personal care, washing and cleaning products, scar and wound treatment

Terphenyl, hydrogenated

vPvB

Heat transfer fluid, plastics, adhesives, sealants

Dicyclohexyl phthalate (DCHP)

Toxic for reproduction, Endocrine disrupting  

Phlegmatizer in organic peroxides, plasticiser in polymers

Disodium octaborate

Toxic for reproduction

Paints, adhesives, construction materials

Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride, TMA)

Respiratory sensitising properties

The substance has no uses in the scope of authorisation but is recommended based on grouping considerations as it could potentially replace two structurally similar substances (HHPA and MHHPA) used as epoxy resin hardeners that have already been recommended. This is to avoid regrettable substitution.

 

The final decision to include these substances of very high concern (SVHCs) in the Authorisation List will be taken by the European Commission together with the EU Member States and the European Parliament. These decisions will also indicate the sunset date, as well, as the latest application date.

 

Once on Annex XIV, companies will need to apply for authorisation to continue using them.

 

Revision of REACH and CLP regulations

 

The Commission has published two inceptions impact assessments (roadmaps), one on the revision of REACH and the other on CLP, looking for stakeholder feedback. These roadmaps describe possible options on how to change the two pieces of legislations to solve some of the following issues (non-exhaustive list):

 

  • Gaps in knowledge of many substances including intermediates, polymers and substances in the lowest tonnage range and no assessment of risks is required for non-threshold substances.
  • Incomplete information about hazards to human health and the environment
  • The registrant´s safety assessments do not take combination effects of chemicals into account.
  • The authorisation procedure is too heavy and inflexible and the restriction process is too slow to sufficiently protect consumers and professional users against risks from hazardous substances.
  • The control and enforcement is not equally effective in all Member States.

The deadline to submit comments is 1 June 2021. Give comments on REACH | Give comments on CLP

 

Updated guidance on safety data sheets

 

ECHA´s guidance on safety data sheets has been revised in line with the latest version of Annex II to REACH according to Regulation (EU) 2020/878 and translations are now available. The content has been updated to reflect changes introduced by the new legal text, including on nanoforms, the unique formula identifier (UFI), endocrine disrupting properties, and an expanded Section 9 covering physical and chemical properties. It also provides an explanation of the application of the two-year transition period (until 31st December 2022).

 

Existing SDSs compliant with Regulation (EU) 2015/830 may be used only until 31st December 2022, the deadline to update all existing SDSs to be compliant with Annex II.

 

More information is available on ECHA´s website.

 

The European Union sets a limit as UTC for pentachlorophenol under the POP Recast Regulation

 

On 23rd February this year, the European Union published Regulation (EU) 2021/277 amending Annex I to Regulation (EU) 2019/1021 on persistent organic pollutants as regards pentachlorophenol and its salts and esters.

 

Pentachlorophenol (PCP) is toxic to human health and the environment and it is used as preservative for wood, leather and textiles to protect against the attack of moulds, fungus and bacteria.

 

When the POP Recast regulation was published, pentachlorophenol and its salts and esters were listed in Annex I without an Unintentional Trace Contaminant (UTC) limit value. However, the European Commission determined the presence of these substances as an impurity in some articles, including imported textiles and recovered wood chips for the production of wood panels. To allow the continuation of recycling of wood chips and to facilitate the enforcement, a UTC limit equal to or below 5 mg/Kg (0,0005% by weight) was set under “Specific exemption on intermediate use or other specification” in Part A to Annex I to POP Recast Regulation. This limit value applies to PCP, its salts and esters when they are present in substances, mixtures or articles. This amendment became effective on 15th March.

 

In addition, on 2nd February this year, the European Union published Regulation (EU) 2021/115 amending Annex I to POP regulation as regards perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds.

 

Proposal to list chlorpyrifos as Persistent Organic Pollutant (POP)

 

The Council decision asks the European Commission to submit a proposal on behalf of the European Union to list chlorpyrifos (EC 220-864-4, CAS 2921-88-2) in Annex A to the Stockholm Convention on persistent organic pollutants. The manufacture and use of substances in this annex is prohibited.

 

After the submission later this spring, the POPs Review Committee will discuss the proposal next autumn.

 

The Council Decision (EU) 2021/592 was published in the Official Journal on 13th April 2021.

 

Updated Poison centre guidance on Annex VIII to CLP Regulation to help companies notify

 

The guidance on Annex VIII to CLP (version 4.0) has been updated addressing issues identified by certain industry sectors resulting from the requirements for poison centre notifications introduced in 2017.

 

The guidance has been updated to reflect changes concerning bespoke paints that are formulated in stores to satisfy customer demand. Sector–specific solutions have also been included for fuel, petroleum and construction products, as mixtures used in these sectors often have a high or unpredictable composition variability. The solutions help companies to reduce the number of notification and unique formula identifiers (UFIs) required. The labelling and packaging guidance has also been updated to reflect changes concerning bespoke paints.

 

More information is available on ECHA´s website.

 

Updated the Community rolling action plan (CoRAP) for the years 2021-2023

 

The updated Community rolling action plan (CoRAP) for the years 2021 – 2023 lists 58 substances for evaluation by the Member State competent authorities under the substance evaluation process of the REACH Regulation (EC) No 1907/2006 (Articles 44 to 48). The plan contains three newly allocated substances and 55 substances already published in the previous CoRAP update on 18 March 2020. The substances are distributed for evaluation in years 2021, 2022 and 2023 between 16 Member States.

 

Eight of the substances are planned to be evaluated in 2021, while the rest are listed for evaluation in 2022 and 2023. Registrants are invited to consider if dossier updates would be needed to bring new relevant information, for example, on tonnages, use and exposure.

 

More information is available on ECHA´s website.

 

SVHCs list public consultation

 

On 9th March 2021, The European Chemicals Agency (ECHA) opened a public consultation on proposed substances of very high concern (SVCHs) to be included in the Candidate list in the 25th update, in summer 2021. The deadline for receiving comments was until 23th April 2021.

 

The proposed substances are:

 

Name

EC number

CAS number

Consumer uses

1,4-dioxane

204-661-8

123-91-1

There are no consumer uses, but it cannot be excluded that there are uses of substances or related mixtures, where 1,4-dioxane is contained as constituent or impurity.

2,2-bis(bromomethyl)propane1,3-diol (BMP)
2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA)
2,3-dibromo-1-propanol (2,3-DBPA)

221-967-7
253-057-0
202-480-9

3296-90-0
36483-57-5
1522-92-5
96-13-9

Polymer production manufacture of plastics products

2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers

-

-

It is used in many different uses such as coatings and paints, thinners, paint removes; Fillers, putties, plasters, modelling clay; Finger paints, Ink and toners

4,4'-(1-methylpropylidene)bisphenol; (bisphenol B)

201-025-1

77-40-7

It may be used in the manufacture of phenolic and polycarbonate resins and it has a structure similar to Bisphenol A.

Glutaral

203-856-5

111-30-8

In leather tanning, finishing, impregnation and cosmetics/personal care between other uses.

Medium-chain chlorinated paraffins (MCCP) [UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17]

-

-

In rubber articles; Paper products; Textile (fabrics, textiles, apparel, and leather articles); PVC (plastic articles); Production of cables (machinery, mechanical appliances, electrical/electronic articles).

Orthoboric acid, sodium salt

237-560-2

13840-56-7

Uses include solvent and corrosion inhibitor

Phenol, alkylation products (mainly in para position) with C12-rich branched or linear alkyl chains from oligomerisation, covering any individual isomers and/ or combinations thereof (PDDP)

-

-

The substance is further used in the manufacture of chemicals, rubber products and plastic products.

 

For more information, read the official publication on the ECHA website here.

 

Recent Updates regarding REACH

 

The below table showcases a summary of the most recent updates (non-exhaustive) regarding REACH Regulation (EC) No 1907/2006:

 

Summary  of the Most Recent Updates

Date

Subject

Link

26/04/2021

Companies must review registrations transferred from the UK

More than 8 000 UK-based registrations have been successfully transferred to companies in the EU, EEA or Northern Ireland. These companies must review and, if needed, update the information in these registrations.

For more information, visit the ECHA’s website here

21/04/2021

ECHA identified 290 chemicals as candidates for regulatory action

In 2020, ECHA assessed around 1.900 registered chemicals in groups. 290 of these may be candidates for further regulatory risk management at EU level if their hazards are confirmed. Most of these will require more data to be generated and confirmation of hazards before any actions take place.

For more information, visit the ECHA’s website here

24/02/2021

REACH Evaluation Joint Action Plan

Evaluation activities were sped up by checking similar chemicals in groups in a more efficiently manner for the assessment. In 2020, ECHA checked 1900 chemicals to identify needs for further assessment. Registrations for 258 chemicals were also checked for compliance with REACH requirements. Better quality safety data from companies is still needed to clarify the long-term effects of chemicals on human health or the environment.

ECHA published the list of the substances evaluated in 2020 including details on the information requests that have been issued to companies as part of ECHA´s recommendations on how to improve their registration data.

For more information, visit the ECHA’s website here

24/02/2021

Implementation of the REACH action Plan for review/improvement of Registration Dossiers

Lessons learnt from pilot studies in developing voluntary testing strategies to avoid unnecessary animal testing and costs were published in January 2021 and can be applied to future testing strategies.

For more information, visit the ECHA’s website here

17/03/2021

Mapping of the chemical universe progresses

An updated list of mapped substances is now available on ECHA´s website. Registered substances are divided into five pools based on the regulatory actions in place, initiated or considered for them. The mapping will contribute to the annual report on ECHA’s Integrated Regulatory Strategy, which will be published in April. The aim is to have all registered substances screened and allocated to pools by 2027, indicating whether they are:

  • A priority for regulatory risk management;
  • A low priority for further regulatory action; or
  • A priority for data generation.

You can download the list of REACH registered substances divided in pools by clicking here.

For more information, visit the ECHA’s website here

09/03/2021

Substances of Very High Concern identification

ECHA launched on 9th March this year the first public consultation on eight proposals for potential Substances of Very High Concern (SVHC). Four of them are food contact chemicals (FCCs) including: bisphenol B, 1,4-dioxane, medium-chain chlorinated paraffins (MCCP), and phenol alkylation products with C12-rich branched or linear alkyl chains from oligomerization (PDDP).

If the proposals are accepted and the substances are identified as an SVHC, they will be added to the Candidate List for eventual inclusion in the Authorisation List. The deadline for submitting comments is on 23rd April.

For more information, visit the ECHA’s website here

10/03/2021

OECD publishes guidance on identifying chemical alternatives

In March 2021, the Organization for Economic Co-operation and Development (OECD) published a guidance document on the identification and selection of safer chemical alternatives. This guidance aims to advance broader agreement on a general approach and criteria for the selection of safer alternatives, with a focus on chemical substitution and to determine that a chemical alternative is safer than the one it would substitute.

Guidance on Key Considerations for the Identification and Selection of Safer Chemical Alternatives can be consulted here

12/03/2021

ANSES proposes bisphenol B as REACH SVHC

The French agency for food, environmental and Occcupational Health&Safety (ANSES) proposes listing bisphenol B as a substance of very high concern (SVHC) under REACH regulation and preventing the substitution of BPA. According to a review by ANSES, bisphenol B has similar or even more pronounced endocrine disrupting properties compared to bisphenol A which it is intended to replace.

Public consultation was opened until 23rd April 2021.

For more information, visit the ANSES website here

04/03/2021

Recommended occupational exposure limits for titanium dioxide nanoparticles

Titanium dioxide in nanoparticle form or TiO2-NP is one of the most widely used nanomaterials in various industrial sectors in France. It is therefore a major source of potential exposure in the workplace.

ANSES is now recommending an occupational exposure limit (8h-OEL) of 0.80 microgram per cubic metre. In addition, due to the lack of available data on the immediate or short-term effects of TiO2-NP and in accordance with its methodological guide, ANSES also recommends not exceeding the concentration of 4 micrograms per cubic metre over a 15-minute period. Compliance with this value should help limit the size and number of exposure peaks over the working day.

For more information, visit the ANSES website here

12/03/2021

European Commission proposes a change on intermediate criteria under REACH regulation

Intermediate substances are exempt from authorisation process and also require less data requirements for REACH registration.

However, according to the 38th meeting of Competent Authorities for REACH and CLP (CARACAL) that took place on 3rd – 4th March this year, the European Commission considered making changes to REACH on the definition of intermediate uses or to complement those criteria by more explicit provisions following the Judgment of the Court of Justice in case e C-650/15/P (“Acrylamide Judgment”).

The preparatory work will include options to amend the legal text on intermediates according to Article 3(15) and the revision of the existing guidance.

Summary conclusions of the 38th Meeting of Competent Authorities for REACH and CLP (CARACAL) can be consulted here

16/03/2021

Supporting Montenegro and Serbia to prepare for EU chemicals laws

ECHA supports the accession countries to build capacity ahead of joining the EU. A study has assessed the gaps and needs of aligning to and implementing EU chemicals legislation such as REACH, CPL, BPR and PIC regulations in Montenegro and Serbia and proposes national action plans on how to move forward. 

For more information, visit the ECHA’s website here

 

Other interesting links about REACH

 

 

Recent Updates regarding CLP

 

The below table showcases a summary of the most recent updates (non-exhaustive) regarding CLP Regulation (EC) No 1272/2008:

 

Summary  of the Most Recent Updates

Date

Subject

Link

20/04/2021

Published the 16th ATP of the CLP regulation (esto lo cambié despues de proof reading)

Commission Delegated Regulation (EU) 2021/643 of 3 February 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 1 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures. Some notes set out in subsection 1.1.3 of Part 1 of Annex VI to CLP that generated a degree of uncertainty has been amended at the request of some Member States and stakeholders.

Commission Delegated Regulation (EU) 2021/643 can be viewed here

21/04/2021

Webinar on how to prepare a poison centre notification

The questions and answers session from the poison centre notifications webinar that took place on March 31 is now published. You can also watch the recording and presentations.

The webinar gave useful tips on how to prepare a poison centre notification, and is particularly helpful if you are new to dossier preparation, your dossier has failed the validation rules or you need to update your notification.

For more information, visit the ECHA’s website here

07/04/2021

Overview of Member States decisions in relation to implementation of Annex VIII to CLP Regulation (Poison Centre Notification)

In order to facilitate companies the notification process, ECHA has published a visual summary document that shows the status of each Member State.

Overview of Member States decisions in relation to implementation of Annex VIII to CLP Regulation is available here

18/03/2021

EU proposes to update EU CLP Regulation to cover endocrine disruptors

The European Commission is proposing that endocrine disrupting chemicals (EDCs) be classified under CLP as either ‘category 1: known or presumed’ or ‘category 2: suspected’ and to separate out human health endocrine disrupters from environmental ones. In addition, the definition of an endocrine disruptor is expected to be completed by the end of 2021.

Expected concentration limits would be in line with current CMRs (≥0,1% for Category 1 and ≥1% for Category 2).

The drafting proposal for revision of CLP is expected on September 2021 and its adoption by the Commission at the end of this year.

For more information, visit the ECHA’s website here

10/02/2021

ANSES proposes a classification under the CLP Regulation for the substance hexyl salicylate used in cosmetics, household cleaners and detergents

The substance hexyl salicylate, used in cosmetics and household cleaners, can have various effects on health, ranging from allergic skin reactions to abnormal foetal development. In order to better inform and protect consumers, ANSES has submitted a classification proposal to the European Chemicals Agency (ECHA) under the CLP Regulation. If validated, this classification will have direct consequences on the labelling of products containing this substance at European level as follows:

  • May cause an allergic skin reaction; Category 1 (H317)"
  • "Suspected of damaging the unborn child; Category 2 (H361d)"

The public consultation was open until 9th April 2021. On the basis of the opinion issued on the classification of hexyl salicylate by the ECHA´s Committee for Risk Assessment, the European Commission will make its final decision.

For more information, visit the ANSES website here

 

Other interesting links about CLP

 

 

Regulations proposals

 

Please find below a table summarising recent regulation proposals made to the European Commission (Non-exhaustive):

 

Notification number

Countries

Title

2021/262/A

Austria

The legislative amendment transposes requirements from Directive (EU) 2019/904 into national law, specifically updating the Waste Management Act 2002, concerning packaging.

In addition, requirements from the amended Directive 2008/98/EC are being transposed in relation to the extended producer responsibility regime for packaging.

2021/256/NL

Netherlands

In the Netherlands, objects made of gold, silver or platinum must bear a hallmark issued by a designated assay office that guarantees the fineness of the precious metal in question. The assay requirement and the rules for assaying and assay bodies (the designated assay offices) are contained in the Assay Act 2019 [Waarborgwet 2019] (previously notified under Notification No 2018/495/NL) and the Hallmarking Order 2019 [Waarborgregeling 2019] (previously notified under Notification No 2019/422/NL). However, the rules on composite objects contain two gaps. These concern mainly composite objects with a (extremely thin) precious metal top layer. The bill rectifies these two apparent gaps in the Assay Act 2019. This bill was previously notified (2020/347/NL), but is notified again due to some changes to the proposal.

2021/161/P

Portugal

This draft Decree-Law transposes into national law Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (SUP Directive).

2021/160/P

Portugal

This draft Decree-Law regulates Article 321 of Law No 75-B/2020 of 31 December on the 2021 State Budget Law.

This draft legislation prohibits the placing on the market of cosmetic products, hygiene products, detergents and cleaning products containing plastic microspheres consisting of synthetic particles of less than 5 millimetres in diameter.

 

UK

 

New UK authorities’ publications and updates

 

UK authorities have updated the following guidance, documents and corrigendum in relation to import, export and customs for businesses (non-exhaustive list):

 

 

Recent updates regarding UK REACH and GB CLP

 

The below table showcases a summary of the most recent updates (non-exhaustive) regarding UK REACH and GB CLP:

 

Summary  of the Most Recent Updates

Date

Subject

Link

28/10/2021

Downstream user import notification (DUIN)

28/10/2021: Deadline to submit a notification to the Agency regarding the substances you wish to continue importing into the GB from the EU.

It should be noted that, having notified under Article 127E, you are not obliged to register unless you wish to continue importing the notified substance after 300 days plus either two (28/10/2023), four (28/10/2025) or six (28/10/2027) years of the end of the transition period.

This only needs to be done once per legal entity and covers all substances that you wish to continue importing from the EU.

For more information visit HSE´s website

01/04/2021

Following public consultation, HSE published the statement from UK REACH Agency on the use of independent scientific knowledge and advice (ISA)

For more information visit HSE´s website

31/03/2021

Questions and answers for companies

In this Q&A section, you can find detailed advice on the impact of the UK’s withdrawal from the EU on the chemical legislations managed by ECHA i.e. REACH, CLP, BPR, PIC and POPs. There is also a section on Northern Ireland where these regulations continue to apply. 

For more information visit ECHA´s website

23/03/2021

Restrictions under UK REACH for first time

Government has laid out plans for restriction work that will be carried out in the first year of UK REACH. The UK REACH programme includes plans to initiate the restriction process on lead ammunition widely used in the shooting industry, harmful substances in tattoo inks and permanent make-up and per- and polyfluoroalkyl substances (PFAS).

For more information visit GOV.UK website

19/03/2021

Submitting chemicals information to the National Poison Information Service (NPIS)

On 1 January 2021, the GB CLP Regulation came into force. GB-based importers and downstream users, and NI-based downstream users directly supplying the GB market with qualifying Northern Ireland goods, are encouraged to voluntarily submit information relating to emergency health response, and preventative measures on hazardous mixtures placed on the GB market, to NPIS using a safety data sheet (SDS).

For more information visit HSE´s website

 

US

 

TPCH adopts the updates model legislation for packaging

 

Last June, the Toxics in Packaging Clearinghouse (TPCH) proposed to update their Toxics in Packaging Model Legislation, mainly including the addition of PFAS and phthalates as regulated chemicals. And this proposal has come into effect in February 2021.

 

This newly updated Model Toxics in Packaging Legislation covers following major changes:

 

  • ortho-pthalates may not be present exceed 100 ppm in any package or packaging components;
  • PFAS may not be present above the detection limit in any package or packaging components;

The previous TPCH Model legislation was enacted in 19 states prohibiting the total incidental concentration of the four heavy metals (cadmium, lead, mercury, and hexavalent chromium) above 100 ppm. But it will be up to each state whether to adopt this updated legislation to their existing laws or to adopt a new law to address toxics in packaging no later than two years after this enactment.

 

Details can be found here.

 

California Proposition 65 Reformulations

 

California Proposition 65 is the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’, which has been effective for almost 30 years. Due to the implement of California Proposition 65, more and more court cases are settled to reduce the exposure of carcinogenic and reproductive chemicals by reformulating the consumer products containing such chemicals.

 

In order to keep retailers and manufacturers up-to-date, the highlights of the consent agreement are summarised as below:

 

Product

Chemical

Limit

Case No

Rain gauges with exterior decorations

Lead

100ppm

1.0ug

Out of court

Apple watch protectors/bumpers

iPad case

BPA

Not exceed 3 µg per day of dermal exposure from solid materials

Out of court

Duck calls

BPA

Not exceed 3 µg per day of dermal exposure from solid materials

Out of court

Mobile Phone cases

BPA

BPA-Free

Out of court

Sandals/flats

DEHP, DBP, BBP, DINP, DIDP, DnHP

1,000 ppm of each        

Out of court

Hammer

Lead

90ppm

1.0ug

Out of court

Squeegee Item

Lead

DBP, DEHP and DINP

100ppm of lead

1000ppm each of DBP, DEHP and DINP

Out of court

 

New requirements for packaging and packaging components

 

In February 2021, the Model Toxics in Packaging Legislation was updated by the Toxics in Packaging Clearinghouse (TPCH).

 

This Legislation was developed in 1989 to reduce the amount of heavy metals in packaging and packaging components. TPCH Model Legislation prohibit the intentional use of lead, cadmium, mercury and chromium (VI) in any finished package or packaging component, as well as limiting, the total incidental concentration to 100 parts per million by weight (0.01%).  This legislation was adopted by nineteen states: California, Connecticut, Florida, Georgia, Illinois, Iowa, Maine, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, Washington and Wisconsin.

 

The main changes are as follows:

 

  • The sum of the concentration levels of phthalates should not exceed 100 parts per million by weight (0.01%).
  • Prohibition of sale or distribution of a package or packaging components containing PFAS.
  • Criteria for the identification and prohibition of packaging chemicals of high concern

This legislation shall become effective immediately upon adoption.

 

To read the official news, visit the TPCH’s website here.

 

Toxic-Free Kids Act: Implementation of Phase 3

 

On 1st March 2021, the Oregon Health Authority published Phase 3 of the Toxic-Free Kids Act which requires manufacturers of children's products sold in Oregon to report products that contain one or more high priority chemicals of concern for children's health (HPCCCH), and ultimately remove these chemicals, look for an alternative to make the product less hazardous or seek a waiver approved by the Authority.

 

This Phase indicates detailed requirements for manufacturers of three specific categories of children's products:

 

  • Children under three years old;
  • "Mouthable" items, per ORS 431A.253(8); and
  • Children's cosmetics.

To read the HPCCCH list, visit the Oregon Health Authority website here.

 

Proposal and addition of substances in Proposition 65

 

On 19th March 2021, The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) noticed the state of the following substances:

 

For more information, visit the OEHHA website here.

 

No Action Assurance for flame retardant PIP (3:1)

 

In March 2021, The US Environmental Protection Agency (EPA) announced a 60-day public comment period to collect additional input on five final rules for persistent, bioaccumulative and toxic (PBT) chemicals issued on 6th January 2021 under the Toxic Substances Control Act (TSCA).

 

On 8th March 2021, EPA is issuing a temporary 180-day “No Action Assurance” for prohibition of flame retardant PIP (3:1) because of received comments, for example from the electronics and electrical manufacturing industry. PIP (3:1) is used as a flame retardant and a plasticizer in plastic components such as PVC wire covers and casings which can be found such as in gaming consoles.

 

For more information, visit the EPA website here.

 

Canada

 

Draft guidance document for the notification and testing of new chemicals and polymers

 

The draft guidance is now available for use and comments until 30th June 2021. Comments can be submitted using the online reporting system available through Environment and Climate Change Canada’s Single Window or by email to eccc.substances.eccc@canada.ca. When finalised, this new guidance document will replace the 2005 Guidelines for the notification and testing of new substances – chemicals and polymers prepared to assist notifiers responsible for complying with the New Substances Notification Regulations (Chemicals and Polymers) (the Regulations) of the Canadian Environmental Protection Act, 1999 (the Act).

 

This new guidance document will provide assistance for complying with regulatory requirements, including step-by-step instructions for the completion of a New Substances Notification.

 

International

 

Regulatory proposals notified to WTO

 

The table below summarises the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

 

Notification number

Countries

Title

G/TBT/N/EU/797

Europe

This draft Commission Regulation aims to include within the scope of entries 28 to 30 of Annex XVII to REACH regulation several substances, with the effect of restricting their placing on the market or use for supply to the general public as substances on their own, as constituents of other substances or in mixtures and to impose the requirement to mark packaging with the label "restricted to professional users".

G/TBT/N/PER/129

Peru

The notified draft Technical Regulation establishes the technical and labelling requirements for biodegradable plastic bags in order to ensure that, as part of a circular economy model, no microplastic pollution or hazardous substances are produced as a result of their degradation.

G/TBT/N/MAC/17

Macao

Prohibition of import, export and transit of mercury and amalgam listed in The Minamata Convention on Mercury and contained in the Schedule annexed to Chief Executive's Decision No. 231/2020 in the Macao Special Administrative Region.

G/TBT/N/BRA/1151

Brazil

In March 2021, the Brazilian Ministry of Economy/National Institute of Metrology, Quality and Technology published INMETRO Ordinance No. 123 of February 16, 2021 (Portaria Inmetro No. 123, de 16 de Fevereiro de 2021) as the approved consolidated Technical Regulation for Jewelry and costume jewelry (Consolidated Technical Regulation).

G/TBT/N/EGY/288

Egypt

The Ministerial Decree No. 610/2020 mandating the Egyptian Standard ES 8398 "Safety data sheet for chemical products — Content and order of sections"

G/TBT/N/KOR/944

Korea

A draft revision of safety criteria for children's product

 

Product Recalls / Alerts

 

Below you will find a bimonthly summary table of product recalls and alerts in Europe (Source “RAPEX”) and in the US (Source “CPSC”)

 

Europe

 

RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).

 

The following alerts for chemical risks regarding different type of products have been reported, from week 8 to week 14 of 2021:

 

Chemical risks

Number of alerts

Notes

2

Childcare articles

  • Mattress for babies and toodlers (Childcare): It contains dimethylformamide.  It does not comply with REACH Regulation.
  • Silicone corner protector: It contains short chain chlorinated paraffins (SCCPs) and an excessive amount of bis(2-ethylhexyl) phthalate (DEHP) and diisobutyl phthalate (DIBP). It does not comply with REACH Regulation and with POP Regulation.

3

Clothing, textiles and fashion items

  • Leather gloves and sandals: they contain chromium VI. It does not comply with REACH regulation.

2

Construction products

  • Black rubber mats for lawns and fall protection plate: The product contains an excessive amount of polycyclic aromatic hydrocarbons (PAH)s. The product does not comply with REACH regulation.

65

Jewellery

  • Earrings, necklaces, hair accessories: The product contains excessive amounts of cadmium and of lead. It does not comply with REACH regulation.
  • Earrings, necklaces, hair accessories: The product contains excessive amounts of nickel. It does not comply with REACH regulation.

 

Stationary

  • Thermal paper: The product contains excessive amounts of bisphenol A. It does not comply with REACH regulation.

20

Plastic toy:  Article contains bis (2-ethylhexyl) phthalate (DEHP) and diisobutyl phthalate (DIBP), diisononyl phthalate (DINP). Does not comply with the REACH Regulation.

Balloons: The amount of N-nitrosatable and nitrosatable substances generating n-nitrosodimethylamine (NDMA) substances released by the balloons is too high. It does not comply with the Toy Safety Directive and EN 71-12.

Car toy: The soldered joints of the toy contain an excessive amount of lead. It does not comply with RoHS Directive.

Jumpbag with foam: The foam material in the product contains an excessive amount of the flame retardant tris(2-chloro-1-methylethyl) phosphate (TCPP). It does not comply with the Toy Safety Directive.

Toy slime: The migration of boron from the toy slime is too high. It does not comply with the REACH Regulation and  the Toy Safety Directive and EN 71-3.

 

US

 

Between the 21st February and 20th April 2021, CPSC (Consumer Product Safety Commission) published the following recalls regarding chemical risks: 0 recall.

 

 

Top

Cosmetics & Personal Care


 

 

Check the compliance and safety of your products containing UV filters

 

Sunscreen is designed to protect your skin from the sun's damaging rays, and forms an important part of a complete sun protection strategy. UV filters, mainly used in sunscreen products and some other cosmetics and personal care products, play an important role in maintaining good health and are regularly subjected to specific verifications by scientific committees to ensure their safety and efficacy.

Read more >>

 

Shape your businesses for China’s New Cosmetics Regulation

 

Since 1st January 2021, China's cosmetic sector (the world’s second-largest cosmetic market) has heralding a new era by implementing the Cosmetic Supervision and Administration Regulation (CSAR), replacing the Cosmetics Hygiene Supervision Regulations (CHSR).

Read more >>

 

How to surf the organic and natural cosmetics boom on full compliance and safety?

 

Demand for natural and organic raw materials and ingredients for cosmetics and personal care is on the rise globally. Environmental issues and changes to consumer behavior and lifestyles are creating openings for natural and organic raw materials and ingredients. Although these trends are generating opportunities, regulations and testing pose major challenges for companies seeking access to the market. In this dynamic landscape, certain rules have to be respected regarding natural or organic cosmetic designation and certification.

Read more >>

 

 

Top

Furniture


 

 

Standard for the Flammability of Upholstered Furniture

 

The Consumer Product Safety Commission (CPSC) is issuing a direct final rule on the flammability of upholstered furniture (manufactured, imported, or reupholstered) under the COVID–19 Regulatory Relief and Work From Home Safety Act.

 

This Act mandates that CPSC has to promulgate California Technical Bulletin 117–2013 as a flammability standard under section 4 of the Flammable Fabrics Act.

 

The rule will be effective from 25th June 2021 and compliance with the labeling requirement in § 1640.4 should start by 25th June, 2022.

 

The document is in a comment period until 10th May 2021. If a significant adverse comment is received, a notification in the Federal Register will be published withdrawing this direct final rule before the effective date.

 

For more information, read the official publication on the Federal Register here.

 

CPSC revises safety standard for high chairs

 

On April 2, 2021, the US Consumer Product Safety Commission (CPSC) published a direct rule which revises the mandatory standards for high chairs incorporating by reference the most current version ASTM F404-20.

 

Comparing to the former standard adopted by the CPSC, this rule covers a major amendment by adding performance requirements and test methods for reclined seat high chairs which distinguish from upright seat high chairs.

 

The revised rule 16 CFR 1231 requires that each high chair shall comply with all applicable provisions of ASTM F404-20.

 

This final rules will come into force on July 3, 2021, unless CPSC receives a significant adverse comment by May 3, 2021. Please click here for more information.

 

 

Top

Medical Devices


 

 

Eurofins’ Finland’s Notified Body achieves designation under the new Medical Devices Regulation (EU) 2017/745

 

On April 7th, 2021, Eurofins Expert Services Oy (No. 0537) became a Notified Body designated under the new Medical Devices Regulation (MDR). Eurofins can now offer, to medical device manufacturers worldwide, certification services according to Regulation (EU) 2017/745 for European market access covering an extensive range of medical device technologies1.

 

The new Medical Device Regulation (MDR) enters into full application on May 26th, 2021, with this date marking the end of the transition period between Regulation (EU) 2017/745 and the current European Medical Devices Directives 93/42/EEC (MDD) & 90/385 EC (AIMD).

 

Medical devices currently covered by a valid certificate issued in accordance with these Directives can be placed or put in service on the European Market until May 26th, 2024, and made available until May 26th, 2025, if they continue to comply with either of these Directives and do not undergo any significant changes in the design and intended purpose.

 

In anticipation of this, Eurofins Expert Services Oy identified and implemented the necessary processes to ensure the continuity and quality of its services and allow manufacturers to maintain, on the European market, the medical devices currently covered by certificates of conformity issued under the MDD.

 

If the device undergoes any significant changes in the design or intended purpose, it must undergo certification to the MDR as if it was a new product. Eurofins can guide manufacturers through this process to ensure continuing European market access.

 

In parallel with its successful MDR designation, Eurofins Expert Services Oy, a Notified Body for the Directive 98/79/EC (IVD MDD), applied for its designation under the in vitro diagnostic medical device Regulation (EU) 2017/746 (IVDR). This process is underway, and Eurofins Expert Services Oy is determined to complete it no later than Q4 of 2021.

 

Alongside the MDD, IVD and MDR Notified Body certification services, Eurofins provides a comprehensive suite of medical device solutions, including EMC, Safety and Wireless testing for manufacturers looking to gain global market access and achieve regulatory compliance.

 

For more information about our MDR designation, please contact the Eurofins Finland medical devices team by email  or visit our website.  

 

1 The scope of designation for Eurofins Expert Services Oy is available online, on the NANDO website (New Approach Notified and Designated Organisations), the European Commission's information system.

 

 

Top

Personal Protective Equipment


 

 

Europe

 

Harmonised standards on electrostatic properties

 

On 5th March 2021, the European Commission published the following amendments related to the addition of harmonised standards for protective clothing.

Read more >>

 

SVHCs list public consultation

 

On 9th March 2021, The European Chemicals Agency (ECHA) opened a public consultation on proposed substances of very high concern (SVCHs) to be included in the Candidate list in the 25th update, in summer 2021.

Read more >>

 

Standards updates

 

The following table summarises the most recent standards updates and upcoming dates of withdrawal (non-exhaustive).

Read more >>

 

France

 

Change the Green Dot to the “Triman” logo and Sorting Info in your packagings

 

On 15th March 2021, order N°450160, 450164 was published which requested that the obligation to remove the "Green Dot" does not apply to the French state until 1st January, 2022.

Read more >>

 

US

 

New requirements for packaging and packaging components

 

In February 2021, the Model Toxics in Packaging Legislation was updated by the Toxics in Packaging Clearinghouse (TPCH).

Read more >>

 

Standards updates

 

See the following table summarising some recent ASTM standards updates.

Read more >>

 

Product Recalls / Alerts

 

Below you will find a monthly summary of product recalls and alerts in Europe (Source “RAPEX”).

 

Europe

 

RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).

 

The following alert regarding Personal Protective equipment has been reported, from week 8 to week 15 of 2021.

 

Type of Risk

Number of alerts

Notes

Drowning

1

Lifejacket

Some cylinders of the lifejacket could be empty making inflation of the product impossible.

 

US

 

Between 21st February and 20th April 2021, the CPSC (Consumer Product Safety Commission) published the following recalls: 0 recall PPE products.

 

 

Top

Softlines & Leather


 

 

Europe

 

SVHCs list public consultation

 

On 9th March 2021, The European Chemicals Agency (ECHA) opened a public consultation on proposed substances of very high concern (SVCHs) to be included in the Candidate list in the 25th update, in summer 2021.

Read more >>

 

Standards updates

 

The following table summarises the most recent standard updates and upcoming dates of withdrawal (non-exhaustive).

Read more >>

 

Regulatory proposals notified

 

The following table summarises recent regulatory proposals made to the European Commission (Non-exhaustive).

Read more >>

 

France

 

Change the Green Dot to the “Triman” logo and Sorting Info in your packagings

 

On 15th March 2021, order N°450160, 450164 was published which requested that the obligation to remove the "Green Dot" does not apply to the French state until 1st January, 2022.

Read more >>

 

UK

 

New UK authorities’ publications and updates

 

UK authorities have updated the following guidance, documents and corrigendum in relation to import, export and customs for businesses (non-exhaustive list).

Read more >>

 

US

 

Proposal and addition of substances in Proposition 65

 

On 19th March 2021, The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) noticed the state of the following substances.

Read more >>

 

Toxic-Free Kids Act: Implementation of Phase 3

 

On 1st March 2021, the Oregon Health Authority published Phase 3 of the Toxic-Free Kids Act which requires manufacturers of children's products sold in Oregon to report products that contain one or more high priority chemicals of concern for children's health (HPCCCH), and ultimately remove these chemicals, look for an alternative to make the product less hazardous  or seek a waiver approved by the Authority.

This Phase indicates detailed requirements for manufacturers of three specific categories of children's products:

  • Children under three years old;
  • "mouthable" items, per ORS 431A.253(8); and
  • Children's cosmetics.

For getting the HPCCCH list, consult the Oregon Health Authority website here.

 

New requirements for packaging and packaging components

 

In February 2021, the Model Toxics in Packaging Legislation was updated by the Toxics in Packaging Clearinghouse (TPCH).

Read more >>

 

Standards updates

 

The following table summarises some recent ASTM standards updates.

Read more >>

 

China

 

China publishes updated GB Standards

 

On 1st May 2021, the following standards have been effective as the announcement Nº 22 of 2020 indicated by China National Standardization (SAC).

Read more >>

 

China publishes updated Standards

 

On 19th April 2021, the Ministry of Industry and Information Technology of the People's Republic of China published Announcement Nº 6 of 2021.

Read more >>

 

International

 

Regulatory proposals notified to WTO

 

The following table summarises the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive).

Read more >>

 

Product Recalls / Alerts

 

Europe

 

RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).

Read more >>

 

US

 

Between  21st March and 20th April 2021, the CPSC (Consumer Product Safety Commission) published the following recalls.

Read more >>

 

 

Top

Toys & Childcare


 

 

Europe

 

New requirements of EU Toy Safety Directive

 

On 20th and 21st May 2021, the two Commission Directives (EU) 2019/1922 and 2019/1929 will come into effect.

Read more >>

 

SVHCs list public consultation

 

On 9th March 2021, The European Chemicals Agency (ECHA) opened a public consultation on proposed substances of very high concern (SVCHs) to be included in the Candidate list in the 25th update, in summer 2021.

Read more >>

 

Childcare articles made from bamboo fibres and melamine

 

In the February edition of Eurofins Monthly Bulletin, news about Food Contact Bamboo-Melamine Plastics was published.

Read more >>

 

New European regulatory framework for batteries

 

The European Commission released a proposal on 10th December 2020 related to the Batteries Directive (2006/66/EC).

Read more >>

 

Harmonised marking specifications for wet wipes

 

In December 2020, the European Commission published regulation related to single-use plastics which indicates harmonised marking specifications for wet wipes and other single-use products (Regulation (EU) 2020/2151).

Read more >>

 

Standards updates

 

Please see the following table summarising the most recent standards updates and upcoming dates of withdrawal (non-exhaustive).

Read more >>

 

France

 

Change the Green Dot to the “Triman” logo and Sorting Info in your packagings

 

On 15th March 2021, order N°450160, 450164 was published which requested that the obligation to remove the "Green Dot" does not apply to the French state until 1st January, 2022.

Read more >>

 

Safety in childcare articles

 

In February 2021, The Direction générale de la concurrence, de la consummation et de la répression des fraudes (DGCCRF) published several articles on childcare products and their safety.

Read more >>

 

UK

 

New UK authorities’ publications and updates

 

UK authorities have updated the following guidance, documents, and corrigendum in relation to import, export and customs for businesses (non-exhaustive list).

Read more >>

 

 

US

 

Proposal and addition of substances in Proposition 65

 

On 19th March 2021, The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) noticed the state of the following substances

Read more >>

 

No Action Assurance for flame retardant PIP (3:1)

 

In March 2021, The US Environmental Protection Agency (EPA) announced a 60-day public comment period to collect additional input on five final rules for persistent, bioaccumulative and toxic (PBT) chemicals issued on 6th January 2021 under the Toxic Substances Control Act (TSCA).

Read more >>

 

Toxic-Free Kids Act: Implementation of Phase 3

 

On 1st March 2021, the Oregon Health Authority published Phase 3 of the Toxic-Free Kids Act which requires manufacturers of children's products sold in Oregon to report products that contain one or more high priority chemicals of concern for children's health (HPCCCH), and ultimately remove these chemicals, look for an alternative to make the product less hazardous or seek a waiver approved by the Authority.

Read more >>

 

Recently CPSC publications

 

Please see the following summary list of recent the US Consumer Product Safety Commission (CPSC) publications.

Read more >>

 

The ban on phthalates in toys and childcare articles is maintained

 

In 2017, The United States Consumer Product Safety Commission (CPSC) issued the final rule prohibiting children's toys and child care articles that contain concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP).

Read more >>

 

New requirements for packaging and packaging components

 

In February 2021, the Model Toxics in Packaging Legislation was updated by the Toxics in Packaging Clearinghouse (TPCH).

Read more >>

 

Standards updates

 

The following table summarises some recent ASTM standards updates.

Read more >>

 

Canada

 

Health Canada's Consumer Product Safety Program recent publications

 

On 22nd February 2021, Health Canada published the updated Industry guide to the Glazed Ceramics and Glassware Regulations (GCGR).

Read more >>

 

China

 

China publishes updated GB Standards

 

On the 13th April, 2021, China National Standardization (SAC) approved, in the announcement Nº4 of 2021, the Issuance of the following recommended national standards.

Read more >>

 

China publishes updated Standards

 

On 19 April 2021, the Ministry of Industry and Information Technology of the People's Republic of China published Announcement Nº 6 of 2021, in which 563 industry standards were approved

Read more >>

 

HONG KONG

 

Update of Safety standards for toys and children products

 

On 19 February 2021, the Government of Hong Kong published an amendment related to Toys and Children's Products Safety Ordinance (Cap. 424).

Read more >>

 

AUSTRALIA/ NEW ZEALAND

 

New publication standard for Safety of Toys

 

On 12 February 2021, the standard AS/NZS ISO 8124.3:2021 Safety of Toys, Part 3: Migration of certain elements was published by Standard Australian and Standard New Zealand.

Read more >>

 

International

 

Regulatory proposals notified to WTO

 

The following table summarises the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive).

Read more >>

 

Product Recalls / Alerts

 

Europe

 

RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities).

29 alerts from week 12 to week 15 of 2021 >>

44 alerts reported from week 8 to week 11 of 2021 >>

 

US

 

From 21st February 2021 to 20th April of 2021, CPSC (Consumer Product Safety Commission) published the following recalls.

From 21 February 2021 to 20 March of 2021 >>

From 21 March 2021 to 20 April 2021 >>

 

Top

 

COVID-19 | Testing, inspection and certification of products and devices


 

 

Eurofins labs at work worldwide to keep you healthy and safe

 

Eurofins has developed global leading testing, inspection, regulatory and certification services in the North America, Europe and Asia, focused on medical face masks, gloves and gowns, respiratory protective devices and equipment, its materials and components, as well as disinfectants and hand sanitizers, ensuring that PPE and Medical Devices manufacturers are able to provide the indispensable support needed in the fight against the coronavirus.

 

With a service offering that covers a scope spanning from product concept and risk assessment, Notified Body services, through chemical, biological, physical, mechanical or electrical testing, efficacy and performance evaluations and all the way down to product certification and quality controls, Eurofins strives to be the one-stop solution provider for its clients supplying PPEs and Medical Devices to the healthcare sector worldwide.

 

 More information on this global service offer is available here.

 

Europe

 

Regulatory proposals notified

 

The table below summarises recent regulatory proposals made to the European Commission (Non-exhaustive):

 

Countries

Notification number

Title

Denmark

2021/223/DK

Ordinance on specific measures relating to the supply of face masks in the handling of COVID-19.

 

Standards updates

 

The below table summarises the most recent standards updates and upcoming dates of withdrawal (non-exhaustive):

 

(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

CENELEC / CEN

Reference

Title

Date of Withdrawal (*)

Supersedes

EN 14387:2021

Respiratory protective devices - Gas filter(s) and combined filter(s) - Requirements, testing, marking

2021-08-31

EN 14387:2004 +A1:2008

EN 143:2021

Respiratory protective devices - Particle filters - Requirements, testing, marking

2021-08-31

EN 143:2000/ AC:2005
EN 143:2000/ AC:2002
EN 143:2000/ A1:2006
EN 143:2000

EN ISO 19734:2021

Eye and face protection - Guidance on selection, use and maintenance (ISO 19734:2021)

2021-09-30

 

 

Spain

 

Guidance for the manufacture and selection of masks

 

The Ministry of Industry, Commerce and Tourism has added and published new documents related to hygienic masks. The following is a list of recent publications:

 

Guides for the manufacture of masks and protective clothing

 

 

UK

 

Technical specification for transparent face mask

 

On 1st April 2021, the Department of Health and Social Care published guidance on technical specifications of transparent face masks.

 

This document specifies design and performance requirements for single-use transparent face masks which are intended to provide comparable protection and source control to Type IIR medical masks.

 

Masks complying with this technical specification cannot be referred to as Type IIR medical masks, as that term is defined in EN 14683:2019 and is reserved for products meeting the definition of a medical device that also complies wholly with the requirements for Type IIR medical masks in that standard. Masks complying with this technical specification may however meet some of the requirements of EN 14683:2019.

 

For more information, read the official publication on the GOV.UK website here .

 

 

Northern Ireland

 

Mandatory face mask use in church and worship places

 

On 9th April 2021, the Department of Health published The Health Protection (Coronavirus, Wearing of Face Coverings) (Amendment) Regulations (Northern Ireland) 2021.

 

These Regulations amend the Health Protection (Coronavirus, Wearing of Face Coverings) Regulations (Northern Ireland) 2020 in order to require members of the public to wear face coverings whilst inside a church or other religious premises, and on transport services, because of the serious and imminent threat to public health which is posed by the incidence and spread of severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) in Northern Ireland. They replace provisions originally made in the Health Protection (Coronavirus, Restrictions) (No. 2) Regulations (Northern Ireland) 2020. It come into operation on 9th April 2021.

 

For more information, read the official publication on the GOV.UK website here.

 

Product Recalls / Alerts

 

Below you will find a monthly summary of product recalls and alerts in Europe (Source “RAPEX”).

 

Europe

 

RAPEX (European Commission Rapid Alert System for dangerous non-food products – Alerts reported by EU national authorities)

The following 15 alerts regarding Personal Protective equipment have been reported, from week 8 to week 15 of 2021.

Type of Risk

Number of alerts

Notes

Health risk/ other

3

Particle filter mask

It advertises a protective potential against particles, but its filtering capacity has not been tested by a relevant competent European conformity assessment body. It does not comply with the Personal Protective Equipment Regulation.

1

Particle filter mask

The product bears a CE marking but is not certified as protective equipment by a relevant body. The labeling is confusing because on the cardboard box the mask is declared to be  “non-medical” , but also claims to meet EN 14683: 2019.

3

Particle filter mask

The product advertises a protective potential against (viral) particles but its filtering capacity has not been certified by the relevant (European) body.

1

Particle filter mask

The product advertises a protective potential against particles but its filtering capacity has not been tested by a relevant competent European conformity assessment body, and it misuses the CE marking and the model name of a different product from the same manufacturer, which is certified. The packaging of the two being identical, there is no possibility for the consumer to see that it is not the certified product.

6

Particle filter mask

The particle/filter retention of the material is insufficient (measured values too low).

1

Particle filter mask

The mask is presented as providing a protective function, however these claims are not backed by evidence. This could create a false sense of safety to the wearer of the mask and thus, even if combined with other recommended measures, not protect its user.

 

US

 

Between  21st February and 20th April 2021, the CPSC (Consumer Product Safety Commission) published the following recalls0 recall PPE products.