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Media Centre >> News >> Regulatory updates 11-2021

Consumer Products | Bimonthly bulletin | November 2021

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Eurofins newsflash Consumer Products

 

Chemical  |  Cosmetics & Personal Care  |  Personal Protective Equipment  |  Softlines & Leather  |   Toys & Childcare  COVID-19 

 

 

Chemical


 

 

Europe

 

REACH - SCIP database published

 

You can now access data from the EU’s first public database of substances of very high concern in products, SCIP. It aims to allow consumers to make more informed purchasing choices and help waste operators to further develop the re-use of articles and the recycling of materials. The SCIP database now displays more than four million article notifications and the most commonly notified product categories in the database are:

 

  • Furniture
  • Articles made of rubber
  • Electronic equipment and their parts
  • Measuring instruments and their parts
  • Machinery and their parts
  • Vehicles and their parts

The most commonly notified substances of very high concern are: lead, lead monoxide, lead titanium trioxide, silicid acid, lead salt and “Dechlorane Plus TM”.


For more information, visit the ECHA website here.

 

REACH - The next EU-wide enforcement project (REF-11) in 2023 will control safety data sheets and compliance with REACH restrictions

 

The EU-wide enforcement project (REF-11) in 2023 will look at the quality of information in safety data sheets, due to the poor quality of information detected in many earlier enforcement projects.

 

In addition, the project will check compliance with the revised requirements under Annex II to REACH according to Regulation (EU) 2020/878. Existing SDSs compliant with Regulation (EU) 2015/830 may be used  until 31st December 2022, the deadline to update all existing SDSs to be compliant with Annex II.

 

The EU-wide enforcement project (REF-11) will also control compliance with REACH restrictions according to the latest revised compendium of analytical methods.

 

The Forum will prepare the project in 2022, run inspections in 2023 and report in 2024.

 

For more information, visit the ECHA website here.

 

Additional Recent Updates regarding REACH

 

The table below 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

19/10/2021

Joint Statement on the enforcement of EU chemical legislation

Ahead of the 2nd meeting of the High-Level Roundtable on the Chemicals Strategy for Sustainability, CEFIC, EURATEX and other members are calling on the European Commission to prioritise actions to improve enforcement of the EU chemicals and product safety laws.

Joint statement on the enforcement of EU chemical legislation can be found here

13/10/2021

New guideline reduces animal testing and protects from allergies caused by chemicals

The ECHA has published advice to registrants on how to reliably combine different sources of alternative data when assessing skin sensitisation of chemicals. This reduces the need to test on animals, while protecting people from allergies. The advice is based on a recent OECD guideline.

For more information, visit the ECHA website here

10/09/2021

Risks from chemicals in baby diapers not demonstrated

ECHA’s Committee for Risk Assessment (RAC) found that there is not enough scientific evidence to conclude that certain chemicals found in single-use diapers or nappies pose a risk. This conclusion follows an evaluation of a proposal to restrict formaldehyde, PAHs, dioxins, furans and PCBs in baby diapers throughout the EU.

For more information, visit the ECHA website here

 

Other interesting links about REACH from ECHA’s website

 

 

Recent Updates regarding CLP

 

The table below 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

09/10/2021

Translations available for Guidance on harmonised information relating to health emergency response – Annex VIII to CLP

The Guidance on harmonised information relating to health emergency response – Annex VIII to CLP is now available in 23 EU languages.

The harmonisation of the notification at EU level is established by the Annex VIII of the CLP Regulation, whose main point is the generation of a UFI code associated to each composition, which must appear on the product label.

To read the guide in your preferred language, select it at the top of the ECHA website here

20/09/2021

New guide available on classifying and labelling titanium dioxide

The classification and labelling requirements for titanium dioxide (TiO2) changed in February 2020 and, as of 1 October 2021 and following Delegated Regulation (EU) 2020/2017, new classification and labelling requirements came into force.

The guide helps companies understand how mixtures containing titanium dioxide (TiO2) need to be classified and labelled following its classification as carcinogenic if inhaled.

The new Guide on the classification and labelling of titanium dioxide can be found here

 

Other interesting links about CLP from ECHA’s website

 

 

Technical publications

 

Please find below a table summarising recent technical publications (non-exhaustive):

 

Date

Entity

Comments

01/07/2021

German Federal Institute for Risk Assessment (BfR)

The update concerns BfR Recommendations on food contact materials for rubber:

  • XXI: Commodities based on natural and synthetic rubber
  • XXI/1: Commodities based on natural and synthetic rubber in contact with food
  • XXI/2: Special consumer goods made of natural and synthetic rubber and of lattices made of natural and synthetic rubber (formerly special category)

 

France

 

The identification of endocrine disruptors in consumer products

 

On 25th August 2021, the French Authorities published the following Decree relating to law AGEC (the fight against waste and the circular economy):

 

Decree n ° 2021-1110 of 23 August 2021 relating to the provision of information allowing the identification of endocrine disruptors in a product.

 

The aim of the decree is the provision of information to identify endocrine disruptors in a product placed on the market. Thus, it requires that any person placing products containing substances exhibiting endocrine disrupting properties on the market publishes a list of these products and the substances that each of them contains. This publication must be released in an open format, allowing collaborative platforms to use this information and thus better inform consumers. The obligation relating to the provision of information regarding the identification of endocrine disruptors in a product placed on the market applies no later than six months after the publication of the order fixing the list of substances with disrupting properties.

 

UK

 

Recent updates regarding UK REACH and GB CLP

 

The table below 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

19/10/2021

UK REACH: Grandfathered Registrations Notified Substances List

The UK Department for Environment, Food & Rural Affairs – DEFRA, published UK REACH: Grandfathered Registrations Notified Substances List. The list includes all substances notified to the Health and Safety Executive (HSE) on or before 1 July 2021 and contains the name of the substance, CAS number and EC number.

For more information visit the HSE website

12/10/2021

ECHA Public consultation: call for comments

The Great Britain Mandatory Classification and Labelling (GB MCL) process includes the consideration of information gathered from public consultations, conducted by HSE or international bodies such as the European Chemicals Agency (ECHA).

ECHA has announced a public consultation on the following proposal for harmonised classification and labelling (CLH):

  • Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (EC: 258-004-5; CAS: 52556-42-0). Chemical registered under REACH.

Scientific and technical information should be submitted directly to the ECHA using their commenting webform by 3 December 2021. Comments will be published on ECHA´s website.

For more information visit the ECHA website.

Previous consultations can be found here

10/10/2011

Draft recommendation for inclusion of substances in Annex 14 of UK REACH

Periodically, the HSE is required to recommend priority substances to be included on the authorisation list (Annex 14) of UK REACH. Before submitting this recommendation, the HSE is required to make it publicly available on its website, inviting all interested parties to comment.

The two substances concerned are disodium octaborate and dicyclohexyl phthalate (DCHP). Both substances are in the SVHC list of substances recommended for its inclusion in Annex XIV according to EU REACH with other 5 substances in April this year.

Consultations close on the 30th November 2021.

Draft recommendation of priority substances to be included in Annex 14 of UK REACH can be found here

 

US

 

New AATCC method for release of fiber fragments

 

The American Association of Textile Chemists and Colorists (AATCC) published the Test Method for Fiber Fragment Release During Home Laundering (AATCC TN 212-2021).

 

It was developed with the aim of combating aquatic pollution caused by the microplastics and microfibres that garments shed during home laundering.

 

The main points are:

 

  • It provides a standardised method for quantifying fiber fragments shedding.
  • It defines standard nomenclature with the terms fiber fragment and microfiber or microplastics.
  • It provides a means of accelerated laundering setting.
  • It applies to man-made fibers, natural fibers and blends.

For more information, consult the AATCC website here.

 

US | California

 

The first Prop 65 notices of BPA in textiles

 

In September 2021 the first notices about Bisphenol-A (BPA) in textiles according to California Proposition 65 were issued in 60-Day Notice.

 

After extensive testing, BPA was found in baby, children’s, and women’s socks at a level exceeding the safe harbor limit of the chemical according to California law. BPA is linked to cancer and numerous other serious health concerns.

 

The notice can be found on the State of California Department of Justice website here.

 

California approved Bill No. 652 to regulate the presence of PFAS in juvenile products

 

On 5th October 2021, the governor of the US State of California approved the Bill Nº 652 to regulate the presence of Perfluoroalkyl and polyfluoroalkyl substances (PFAS) in juvenile products.  On and after July 1, 2023, a person, including but not limited to, a manufacturer, shall not sell or distribute in commerce in this state any new, not previously owned, juvenile product that contains regulated PFAS chemicals.

 

Regulated PFAS means either of the following:

 

  • PFAS that a manufacturer has intentionally added to a product and that have a functional or technical effect in the product, including, but not limited to, the PFAS components of intentionally added chemicals and PFAS that are intentional breakdown products of an added chemical that also has a functional or technical effect in the product.
  • The presence of PFAS in a product or product component at or above 100 parts per million, as measured in total organic fluorine.

“Juvenile product” means a product designed for use by infants and children under 12 years of age, including, but not limited to:

 

A baby or toddler foam pillow

Changing pad

Floor playmat

Bassinet

Child restraint system for use in motor vehicles and aircraft

Highchair

Bedside sleeper

Co-sleeper

Highchair pad

Booster seat

Crib mattress

Infant bouncer

Infant carrier

Infant seat

Infant sleep positioner

Infant swing

Infant travel bed

Infant walker

Nap cot

Nursing pad

Nursing pillow

Playmat

Playpen

Play yard

Polyurethane foam mat

Pad or pillow

Stroller

Portable foam nap mat

Portable infant sleeper

Portable hook-on chair

Soft-sided portable

Crib

Toddler mattress

 

The following products are excluded:

 

  • Children’s electronic products, including, but not limited to, a personal computer, audio and video equipment, calculator, wireless phone, game console, handheld device incorporating a video screen, or any associated peripheral such as a mouse, keyboard, power supply unit, or power cord.
  • Medical devices.
  • An internal component of a juvenile product that would not come into direct contact with a child’s skin or mouth during reasonably foreseeable use and abuse of the product.
  • Adult mattresses.

It will be effective from 1st July 2023.

 

For more information, consult the official publication here.

 

US | Oregon

 

“Unit” clarification for application of the Toxic Free Kids Act

 

On 26th August 2021, the Oregon health authority published the temporary administrative order with the aim to clarify the reporting of children’s products under the Toxic Free Kids Act.

 

The main point of the clarification is the “Unit” definition, which has been defined as having the same meaning as “component part”. This point is important because the law requires reporting of the HPCCCHs that are present in amounts greater than 100 ppm (0.01 %). The authorities think that a situation could arise where a HPCCCH might exceed this reporting limit in a component part of a product, but not in the entire product.

 

For more information, consult the official publication (PH 40-2021) here.

 

China

 

China released GB Standards

 

Recently, the State Administration for Market Regulation (SAMR) and the Standardization Administration of the People’s Republic of China (SAC) jointly published announcement no.09 and 12 (in Chinese) of 2021 to approve and release a batch of GB standards related to chemical substances.

 

The table below lists some of these standards (non-exhaustive list):

 

Furniture

GB/T 40904-2021

Methods for the determination of prohibited substances in furniture products and related materials—Azo dyes

Initial

2022-05-01

GB/T 40906-2021

Methods for the determination of prohibited substances in furniture products and related materials—Certain phthalate esters

Initial

2022-05-01

GB/T 40907-2021

Methods for the determination of prohibited substances in furniture products and related materials—2,4-diaminotoluene and 4,4'-methylenedianiline

Initial

2022-05-01

GB/T 40908-2021

Methods for the determination of prohibited substances in furniture products and related materials—Flame retardants

Initial

2022-05-01

GB/T 40971-2021

Methods for the determination of prohibited substance in furniture products and related materials—Polycyclic aromatic hydrocarbons

Initial

2022-05-01

Jewellery

GB/T 17832-2021

Silver jewellery alloys—Determination of silver—Volumetric (potentiometric) method using potassium bromide

GB/T 17832-2008

2022-05-01

GB/T 18996-2021

Silver jewellery alloys—Determination of silver—Volumetric(potentiometric) method using sodium chloride or potassium chloride

GB/T 18996-2003

2022-05-01

 

Brazil

 

New requirements for Baby Bottles

 

On 24th August 2021, Inmetro (Brazil’s Ministry of Economy/National Institute of Metrology, Quality and Technology) published an amendment to the Ordinance No. 216 related to Baby Bottles.

 

The Ordinance No. 2013 was published on 5th May 2021 and came into force in June 2021.

 

Its aim is to establish criteria, requirements and procedures to assess the conformity of bottles and teats, under a health surveillance regime with a safety focus and through the certification mechanism, to prevent consumption accidents. The conformity assessment must be carried out by a Product Certification Body, established in Brazil and accredited by Inmetro.

 

The complementary documents for the conformity assessment requirements were changed with the amendment published in August. The list of updated complementary documents are:

 

Reference

Title

Law No. 11,265, of January 3, 2006

Regulates the sale of foods for infants and children of early childhood and also products related to childcare.

RDC Resolution No. 56, of November 16, 2012, or substitute

It establishes the positive list of monomers, other starters and polymers authorised for the preparation of plastic containers and equipment in contact with food, the prohibition of the use of Bisphenol-A in baby bottles and other measures.

Resolution RDC No. 123, of June 19, 2001, or substitute

Technical regulations on elastomeric containers and equipment in contact with food.

Resolution RDC No. 51, of November 26, 2010, or substitute

Provides for the regulation of migration in plastic materials, packaging and equipment intended to come into contact with food.

RDC Resolution No. 52, of November 26, 2010, or substitute

Provides for the regulation of colourants in plastic containers and equipment intended to be in contact with food.

Resolution RDC No. 17, of March 17, 2008, or substitute

Provides the positive list of additives for plastic materials intended for the preparation of packaging and equipment in contact with food.

Resolution RDC No. 221, of August 5, 2002, or substitute

Provides for the regulation of pacifiers, teats, baby bottles and teat protectors

Anvisa Resolution No. 105, of May 19, 1999, or substitutes

Provides for the regulation of general provisions for plastic containers and equipment in contact with food.

Ordinance No. 27, of March 18, 1996

Provides for the regulation of glass and ceramic containers in contact with food.

Inmetro ordinance in force

General requirements for product certification - RGCP.

ABNT NBR 13793: 2012

Safety of baby bottles and bottle teats

ABNT NBR 5426: 1989

Sampling plans and procedures for inspection by attributes.

 

South Korea

 

DIBP added in the phthalates restriction list for children’s product

 

On 19th July 2021, South Korea’s Ministry of Trade, Industry and Energy (MOTIE) published the notice No. 2021-132 which indicated that Di-isodecyl phthalate (DIBP - CAS number 68515-49-1/26761-40-0) has been added to the restricted phthalates list ( DEHP, DBP,BBP, DINP, DIDP and DnOP) under the Common Safety Standards for Children’s Products (CSSCP). It will become effective on 1st January of 2022.

 

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/CHN/1618

China

National Standard of the P.R.C., Limit of Harmful Substances of Furniture

This standard specifies the terms and definitions, requirements, test methods and judgement inspection results for harmful substances in furniture. This standard is applicable to all types of furniture products.

G/TBT/N/USA/1775

United States

Octamethylcyclotetra-Siloxane (D4); Draft Scope of the Risk Evaluation to Be Conducted Under the Toxic Substances Control Act; Notice of Availability and Request for Comments

Notice of Availability and Request for Comments - In accordance with implementing regulations for the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) is announcing the availability of, and soliciting public comment on, the draft scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4).

G/TBT/N/USA/1755

United States

Warnings for Exposures to Glyphosate from Consumer Products New Sections 25607.48 and 25607.49

Proposed rule - The new regulation would further the "right-to-know" purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as "Proposition 65", and provide warning language tailored for exposures to glyphosate that exceed its NSRL.

G/TBT/N/USA/1784

United States

Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants; Extension of Submission Deadline

Final rule; extension of submission deadline – the EPA is amending the deadline for reporting pursuant to the Toxic Substances Control Act (TSCA) Health and Safety Data Reporting rule, which requires manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to the EPA. Specifically, the EPA will be amending the deadline from 27 September 2021 to 1 December 2021 for 20 of the 50 chemical substances and to 25 January 2022 for 30 of the 50 chemical substances.

G/TBT/N/USA/1788

United States

Significant New Use Rules on Certain Chemical Substances

Proposed rule – the EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of pre-manufacture notices (PMNs) .

 

Technical publications

 

Please find below a table summarising recent technical publications (non-exhaustive):

 

Date

Entity

Comments

01/09/2021

KATS

(Korean Agency for Technology and Standards)

Results of Safety Investigation for Children's Products (in Korean)

KATS published the results of the 2021 safety investigation plan about toys (Children’s toys, educational toys and school supplies). The hazardous chemicals  and durability was checked for this kind of product.

 

 

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Cosmetics & Personal Care


 

 

ALT-SPF consortium partnership to evaluate alternative in vitro sunscreen testing methods

 

A consortium of users and developers of sun protection factor (SPF) tests will identify, characterise, and evaluate alternative sunscreen testing methods. The objective of the ALT-SPF partnership is to facilitate the development of new testing methods that are less invasive, more precise, and more cost-effective than ISO 24444. The partnership will test a set of 32 sunscreen samples, covering a large spectrum of product types, by using the current gold standard – ISO 24444 – along with five alternative methods, including in vitro, in silico and non-invasive in vivo testing, over the next 12 months. The results of the study will be published in a peer-reviewed journal and will serve norming or standardisation bodies as a basis for harmonising and developing standard methods for sun protection.

 

Eurofins Dermscan Poland, part of Eurofins Cosmetics & Personal Care, contributes to the ALT-SPF Consortium by providing testing of the alternative in vitro SPF method.

 

With a team of experts actively involved in in vitro and in vivo sun-care studies, Eurofins is committed to remaining an active player in the future of regulatory solar testing.

 

Contact us if you’d like us to manage the different development steps of your international solar projects, from regulatory and toxicological support, in vitro & in vivo tests, and quantification of UV filters / benzophenone / benzene, to measuring environmental impact, and more.

 

Ensure product safety and increase customer trust and confidence with IFS HPC

 

As a cosmetics and personal care producer, the implementation of an independent 3rd party certification to the IFS HPC standard will ensure compliance with the highest product safety requirements, effective use of resources, reduction of time spent in audits, access to a larger scope of retailers, and increased market confidence in your products.

 

Eurofins experts can support you with the implementation of an IFS HPC certification programme and, moreover, help you to get ready for the new Version 3, due to be published in March 2022 and made mandatory for application on January 2023.

 

Adding capabilities and scale through investments

 

Our company has expanded over the years through acquisitions, strategic partnerships and investments. Today, we continue to grow our global footprint along with our capabilities in order to meet our customers’ evolving needs.

 

We are thrilled to announce the opening of 2 new labs:

 

  • Our new 1,000 sqm clinical studies facility in the heart of Winston-Salem, North Carolina, USA. Eurofins CRL, North Carolina has decades of experience in testing SPF products and, with the expansion to our new site, we now also offer Clinical Safety Testing. Our new testing offerings in North Carolina will include Human Repeat Insult Patch Testing (RIPT), Dermatological Safety in Use (SIU) as well as Consumer Perception (CP) studies.
  • Our new 300 sqm microbiology laboratory facility in Aix-en-Provence, France. Eurofins ATS is a global expert in microbiology testing for cosmetics, hygiene and detergents. Our lab has built a strong reputation in microbiological control (R&D and Routine Quality Control) and in Identification & Characterisation.

Eurofins Cosmetics & Personal Care is present in almost 15 countries with over 26 labs and we continue to build our global footprint in high-growth markets.

 

Start looking at microplastics

 

Around 145 000 tonnes of microplastics are estimated to be used in the EU/EEA each year (ECHA).

 

Microplastics are solid plastic particles composed of mixtures of polymers and functional additives. Microplastics can be unintentionally formed or deliberately manufactured and added to products for specific purposes which can be harmful to the environment. 

 

The European Chemicals Agency (ECHA) published its recommendations to the European Commission several years ago on future measures which will restrict the use of intentionally added microplastics in the EU. These upcoming restrictions are likely to come into force in early 2022, with a transition period to give producers time to comply with the regulations, and will impact the cosmetic industry’s use of microbeads, glitters and encapsulated fragrances.

 

Once the legislation is applied, new measures will likely include a threshold of the concentration of microplastics in a mixture, along with labelling and reporting requirements.

 

Eurofins takes product safety and environmental protection very seriously. That’s why our experts responded early to concerns over microplastics by developing quantitative methods to determine the presence/absence of microplastics, identify and qualify polymers, and determine the plastic composition of packaging.

 

Contact our sales team now to start looking at your product portfolios and formulations, allowing you to understand what products would be affected by the upcoming restrictions and avoid future regulatory issues.

 

Design the next make-up generation

 

How do you create and deliver ethnic colour cosmetics? Or develop and launch natural, organic and vegan make-up products? Or design and produce sustainable colour solutions and reusable cottons?

 

Eurofins supports clients to launch the latest innovative make-up products by offering a complete analytical testing programme, including multicentric clinical studies, a dedicated vegan verification programme, performance and safety testing of reusable cottons, wipes, etc…

 

The analytical programme relies on a network of laboratories around the world to meet local requirements and to ensure a wide range of tests, including but not limited to PFAS identification, quantification of nourishing ingredients, determination of heavy metals, etc...

 

Our clinical centres allow us to carry out studies on different sites across the 5 continents, providing access to diversified panellists with a variety phototypes and in different climates, in order to meet the current and future challenges of make-up development.

 

 

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Personal Protective Equipment


 

 

Europe

 

New European recommendations for PPE’s market surveillance

 

On 2nd September 2021, European Commission published the following recommendation related to personal protective equipment (PPE):

 

RECOMMENDATIONS COMMISSION RECOMMENDATION (EU) 2021/1433 of 1 September 2021 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat

 

It adopts new points which the authorities must follow and comply with in market surveillance procedures of this type of goods.

 

Below a summary table with the recommended points:

 

Market surveillance procedures

Point

Procedure

1

From 1st October 2021, Market surveillance authorities should no longer authorise PPE which are not according with Article 19 of Regulation (EU) 2016/425.

After 1st October 2021, PPE in accordance with points 7 or 8 of Commission Recommendation (EU) 2020/403 cannot be placed on the Union market

2

Medical devices, which are not in accordance with Article 52 of Regulation (EU) 2017/745, will be able to be authorised to be made available on the Union Market, only by following the procedure for derogations from the conformity assessment procedures laid down in Article 59 of Regulation (EU) 2017/745.

3

PPE or medical devices, which have been authorised in accordance with the mechanisms described in point 7 or 8 of Commission Recommendation (EU) 2020/403, shall only be made available until 31 May 2022.

By means of exception, any such PPE or medical device, which is part of existing stocks may be made available until such stocks are fully exhausted but in any event no later than 31 July 2022.

4

From 1 August 2022, PPE or medical devices have to be in according with  Article 19 of Regulation (EU) 2016/425 or Article 52 of Regulation (EU) 2017/745 and bear a CE marking, in accordance with Article 17 of Regulation (EU) 2016/425 or Article 20 of Regulation (EU) 2017/745, unless, in the case of medical devices, specific derogations from the conformity assessment procedure have been authorised by Member States according to Article 59 of Regulation (EU) 2017/745.

5

A non-compliant PPE product or medical device have to be informed immediately the Commission and the other Member States.

For PPE through the Information and Communication System for Market Surveillance (ICSMS) and notify them in the rapid alert system for dangerous non-food products (Safety Gate/RAPEX).

6

A non-compliant PPE product or medical device

Market surveillance authorities should immediately set in motion the relevant procedures laid down in Chapter VI of Regulation (EU) 2016/425 or Chapter VII of Regulation (EU) 2017/745.

 

For more information, consult the official publication here.

 

Standards updates

 

The below table summarises the most recent standard 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.

 

CEN

Reference

Title

Date of withdrawal(*)

Supersedes

EN ISO 16321-2:2021

 

Eye and face protection for occupational use - Part 2: Additional requirements for protectors used during welding and related techniques (ISO 16321-2:2021)

2024-09-30

 

EN ISO 13688:2013/A1:2021

Protective clothing - General requirements - Amendment 1 (ISO 13688:2013/Amd 1:2021)

2022-03-31

 

EN ISO 18527-2:2021

Eye and face protection for sports use - Part 2: Requirements for eye protectors for squash and eye protectors for racquetball and squash 57 (ISO 18527-2:2021)

2022-03-31

 

 

Spain

 

Guidance for the manufacturing and selection of masks

 

The Ministry of Industry, Commerce and Tourism has issue updated UNE specifications for hygienic masks. The following is a list of recent publications:

 

 

US | California

 

New requirements for recycling claims

 

On 5th October 2021, California Governor Gavin Newsom signed Senate Bill 343 -Environmental advertising: recycling symbol: recyclability: products and packaging. The aim is to provide accurate and useful information about the environmental impact of plastic products.

 

This bill will prohibit a person from offering, selling, distributing, or importing into the state any product or packaging for which a deceptive or misleading claim is made about the recyclability of the product or packaging and will also provide the requirements for information and documentation for the use of the term “recyclable,” the use of a chasing arrows recycling symbol, or other representation that advises consumers to recycle a consumer good.

 

Standards updates

 

The table below summarises some recent ASTM standards updates:

 

Reference

Title

ASTM F3050 - 21

Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment

 

Product Recalls / Alerts

 

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

 

Europe

 

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

 

The following 8 alerts regarding Personal Protective equipment were reported between week 34 and week 41 of 2021.

 

Type of Risk

Number of alerts

Notes

Health risk/ other

7

Particle filter mask

The particle/filter retention of the material is insufficient.

It does not comply with the Personal Protective Equipment Regulation and with EN 149.

1

Particle filter mask

The product bears a CE marking 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.

 

US

 

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

 

 

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Softlines & Leather


 

 

Europe

 

Standards updates

 

The below table summarises the most recent standard 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.

 

CEN

Reference

Title

Date of withdrawal (*)

Supersedes

EN ISO 19957:2021

Footwear - Test methods for heels - Heel pin holding strength (ISO 19957:2021)

31-03-2022

EN ISO 19957:2004/AC:2006
EN ISO 19957:2004

EN ISO 30023:2021

Textiles - Qualification symbols for labelling workwear to be industrially laundered (ISO 30023:2021)

2022-03-31

EN ISO 30023:2012

EN ISO 5470-2:2021

Rubber- or plastics-coated fabrics - Determination of abrasion resistance - Part 2: Martindale abrader (ISO 5470-2:2021)

2022-03-31

EN ISO 5470-2:2003

EN ISO 6450:2021

Rubber- or plastics-coated fabrics - Determination of resistance to liquids (ISO/FDIS 6450:2021)

2022-04-30

 

 

Spain

 

Guidance for the manufacturing and selection of masks

 

The Ministry of Industry, Commerce and Tourism has issued updated UNE specifications for hygienic masks. The following is a list of recent publications:

 

 

France

 

The identification of endocrine disruptors in consumer products

 

On 25th August 2021, The French Authorities published the following Decree related to law AGEC (the fight against waste and the circular economy):

 

Decree n ° 2021-1110 of 23 August 2021 relating to the provision of information allowing the identification of endocrine disruptors in a product.

 

The aim of the decree is the provision of information to identify endocrine disruptors in a product placed on the market.  Thus, it requires that any person placing on the market products containing substances exhibiting endocrine disrupting properties according to the ANSES publishes a list of these products and the substances that each of them contains. This publication will be carried out in an open format allowing collaborative platforms to exploit this information and thus better inform consumers. The obligation relating to the provision of information allowing the identification of endocrine disruptors in a product placed on the market applies no later than six months after the publication of the order fixing the list of substances with disrupting properties.

 

Technical publications

 

Please find below a table summarising recent technical publications (non-exhaustive):

 

Date

Entity

Comments

29/07/2021

DGCCRF

(Direction générale de la concurrence, de la consommation et de la répression des fraudes)

Made in France claim

The origin of products is an essential criterion in the purchasing decision of French consumers and a major stake for the revival of the economy and the modernisation of French industry. Also, the DGCCRF conducted an investigation between 2019 and 2020, in order to control all claims on the origin of non-food products and in particular statements such as "made in France" or statements of local origin.

 

US

 

New AATCC method for release of fiber fragments

 

The American Association of Textile Chemists and Colorists (AATCC) published the Test Method for Fiber Fragment Release During Home Laundering (AATCC TN 212-2021).

 

It was developed with the aim of combating aquatic pollution caused by the microplastics and microfibers that garments shed during home laundering.

 

The main points are:

 

  • It provides a standardised method for quantifying fiber fragments shedding.
  • It defines standard nomenclature with the terms fiber fragment and microfiber or microplastics.
  • It provides a means of accelerated laundering setting.
  • It applies to man-made fibers, natural fibers and blends.

For more information, consult the AATCC website here.

 

US | California

 

New requirements for recycling claims

 

On 5th October 2021, Californian Governor Gavin Newsom signed Senate Bill 343 -Environmental advertising: recycling symbol: recyclability: products and packaging. The aim is to provide accurate and useful information about the environmental impact of plastic products.

 

This bill will prohibit a person from offering, selling, distributing, or importing into the state any product or packaging for which a deceptive or misleading claim is made about the recyclability of the product or packaging and will also provide the requirements for information and documentation for the use of the term “recyclable,” the use of a chasing arrows recycling symbol, or other representation that advises consumers to recycle a consumer good.

 

The first Prop 65 notices of BPA in textiles

 

In September 2021 the first notices about Bisphenol-A (BPA) in textiles according to California Proposition 65 were issued in 60-Day Notice.

 

After extensive testing, the BPA was found in baby, children’s, and women’s socks at a level exceeding  the safe limit of the chemical, according to California law. BPA is linked to cancer and numerous other serious health concerns.

 

To see the notice, consult the State of California Department of Justice website here.

 

US | Utah

 

Utah - New requirement for sterilisation of quilted clothing

 

1st January 2022 is the date limit to add the sterilisation permit number (PER. NO.) in the  textile label of quilted and filling clothing. The State of Utah’s Bedding, Upholstered Furniture and Quilted Clothing Inspection Act has the aim of protect consumers and provide hygienically clean and safe product.

 

It applies to bedding, upholstered furniture, or quilted clothing made in whole or in part with filling material such as cotton, wool, kapok, feathers, down, shoddy, hair, or other material, or a combination of materials, whether loose or in bags, bales, batting, pads, or others.

 

It is important to note that, for this Act, Quilted clothing means a filled garment or apparel, exclusive of trim used for aesthetic effect, or a stiffener, shoulder pad, interfacing, or other material that is made in whole or in part from filling material and sold or offered for sale.

 

For more information, consul the Utah Department of Agriculture and food website here.

 

Standards updates

 

The table below summarises the recent ASTM standards updates:

 

Reference

Title

ASTM D1516 - 05(2021)

Standard Test Method for Width of Leather

ASTM D1814 - 70(2021)

Standard Test Method for Measuring Thickness of Leather Units

ASTM D1815 - 00(2021)

Standard Test Method for Water Absorption (Static) of Vegetable Tanned Leather

ASTM D2207 - 00(2021)

Standard Test Method for Bursting Strength of Leather by the Ball Method

ASTM D2209 - 00(2021)

Standard Test Method for Tensile Strength of Leather

ASTM D2211 - 00(2021)

Standard Test Method for Elongation of Leather

ASTM D2212 - 00(2021)

Standard Test Method for Slit Tear Resistance of Leather

ASTM D2347 - 00(2021)

Standard Test Method for Measuring Area of Leather Test Specimens

ASTM D2813 - 03(2021)

Standard Practice for Sampling Leather for Physical and Chemical Tests

ASTM D6012 - 03(2021) 

Standard Test Method for Determination of Resistance of Leather to (Bleeding) Color Stain Transfer

ASTM D6183 - 00(2021)

Standard Test Method for Tackiness of Finish on Leather

ASTM D2061 - 07(2021)

Standard Test Methods for Strength Tests for Zippers

ASTM D3657 - 03(2021)

Standard Specification for Zipper Dimensions

ASTM F1912 - 21

Standard Specification for Safety of Bean Bag Chairs and Bean Bag Chair Covers

 

China

 

China released GB Standards

 

Recently, the State Administration for Market Regulation (SAMR) and the Standardization Administration of the People’s Republic of China (SAC) jointly published announcement no.09 and 12 (in Chinese) of 2021 to approve and release a batch of GB standards, which are closely related to our industries.

 

The below table lists some of these standards (non-exhaustive list):

 

Clothing, Footwear, Textile, Leather

Standard No.

Standard Name

Superseded Standard

Implementation date

GB 24539-2021

Protective clothing—Chemical protective clothing

GB 24539 -2009,  GB 24540 - 2009, GB/T 29511 - 2013

2022-09-01

GB/T 3903.9-2021

Footwear—Test methods for insoles—Heel pin holding strength

GB/T 3903.9-2005

2022-05-01

GB/T 3903.12-2021

Footwear—Test methods for outsoles—Tear strength

GB/T 3903.12-2005

2022-05-01

GB/T 3903.14-2021

Footwear—Test methods for outsoles—Needle tear strength

GB/T 3903.14-2005

2022-05-01

GB/T 3903.25-2021

Footwear—Test methods for whole shoe—Heel attachment

GB/T 3903.25-2008

2022-05-01

GB/T 20096-2021

Roller skate

GB/T 20096-2006

2022-05-01

GB/T 25036-2021

Children’s canvas rubber footwear

GB 25036-2010

2022-05-01

GB/T 26703-2021

Determination of abrasion resistance for top piece of leather shoes

GB/T 26703-2011

2022-05-01

GB/T 40903-2021

Textiles—Identification of some animal fibres by DNA analysis method—Cashmere,wool,yak and their blends

Initial

2022-05-01

GB/T 40905.1-2021

Textiles—Quantitative analysis of cashmere, wool, other specialty animal fibres and their blends—Part 1: Light microscopy method

Initial

2022-05-01

GB/T 40909-2021

Textiles—Determination of methylcyclosiloxane residues

Initial

2022-05-01

GB/T 40910-2021

Textiles—Evaluation for water resistance and water vapour permeability

Initial

2022-05-01

GB/T 40912-2021

Textiles-Quantitative chemical analysis-Mixtures of polyesteramide with certain other fibers

Initial

2022-05-01

GB/T 40917-2021

Textiles—Determination of perfluorohexane-1-sulphonic acid and its salts

Initial

2022-05-01

GB/T 40920-2021

Leather—Tests for colour fastness—Colour fastness to cycles of to-and-fro rubbing

Initial

2022-05-01

GB/T 40927-2021

Leather—Physical and mechanical tests—Determination of heat resistance of patent leather

Initial

2022-05-01

GB/T 40936-2021

Leather—Physical and mechanical tests—Determination of water repellency of garment leather

Initial

2022-05-01

GB/T 40938-2021

Leather—Physical and mechanical tests—Determination of water penetration pressure

Initial

2022-05-01

GB/T 22930.1-2021

Leather and fur—Chemical determination of metal content—Part 1:Extractable metals

GB/T 22930-2008 (partial)

2022-05-01

GB/T 22930.2-2021

Leather and fur—Chemical determination of metal content—Part 2: Total metal content

GB/T 22930-2008, GB/T 22930-2008(partial)

2022-05-01

 

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/AUS/135

Australia

Review of the information standard - Care labelling for clothing and textile products

The ACCC is proposing to make a new information standard for care labelling for clothing and textiles to allow suppliers the option to provide this information through internationally recognised symbols or written words. The proposal would allow suppliers to comply with relevant parts of either of the following voluntary standards:

  • Australian/New Zealand Standard (AS/NZS 1957:1998 Textiles - Care labelling)
  • International Standard (ISO 3758-2012 Textiles - Care labelling code using symbols)

G/TBT/N/JPN/710

Japan

Partial Revision to the Textile Goods Quality Labeling Regulation
With regard to terms showing composing fibers names for labeling, to change "アクリル系" which means "In which the mass of acrylonitrile accounts for under 15%" to "モダクリル" which means "Modacrylic".

G/TBT/N/BRA/1227

Brazil

Inmetro Ordinance N° 333, 04 August 2021

It consolidates the indication of the nominal content of sewing threads.

 

Product Recalls / Alerts

 

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

 

Europe

 

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

 

The following 2 alerts regarding textile & leather products were reported between week 38 and week 41 of 2021.

 

Type of Risk

Number of alerts

Notes

Chemical

1

Motorcycle jacket

The snap fasteners of the product release an excessive quantity of nickel. It does not comply with the REACH Regulation.

1

Beach sandals

The plastic material of the product contains an excessive amount of dibutyl phthalate (DBP). It does not comply with the REACH Regulation.

 

The following 4 alerts regarding textile & leather products were reported between week 34 and week 37 of 2021.

 

Type of Risk

Number of alerts

Notes

Chemicals

1

Jockstrap: The leather in the product contains chromium VI. It does not comply with the REACH Regulation.

Choking

1

Children's blouse: Small decorative parts can easily detach from the garment. A small child may put them in the mouth and choke on them. It does not comply with the General Product Safety Directive.

Injuries

1

Clothing set: The short trousers have long cords with free ends in the waist area that can become trapped during children's normal activities. It does not comply with the requirements of the General Product Safety Directive and with EN 14682.

Strangulation

1

Girls dress: The product has cords with free ends at the level of the shoulders. These can become trapped during children's normal activities. It does not comply with the requirements of the General Product Safety Directive and with EN 14682.

 

US

 

Between 21st September and 20th October 2021, the CPSC (Consumer Product Safety Commission) published the following recalls: 0 recalls of textile & leather products.

 

Between  21st August and 20th September 2021, the CPSC (Consumer Product Safety Commission) published the following recalls: 1 recall of textile & leather products.

 

Hazard

Number of alerts

Notes

Choking

1

children’s socks: The sock’s pom-pom can detach and is a hazard to young children.

 

 

Top

Toys & Childcare


 

 

Europe

 

Technical publications

 

Please find below a table summarising the most recent technical publications (non-exhaustive):

 

Date

Entity

Comments

10/09/2021

ECHA

(European Chemicals Agency)

Risks from chemicals in baby diapers not demonstrated

ECHA’s Committee for Risk Assessment (RAC) published its opinion on the ANSES’s proposal to restrict substances (formaldehyde, PAHs, dioxins, furans and PCBs ) in single-use baby diapers under the EU’s chemicals legislation.

01/09/2021

DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des fraudes)

Control of the mechanical safety of utensils and containers intended for feeding children (In french)

DGCCRF published the report about the checks to children's cutlery that were susceptible to breakage - those made of materials such as melamine, wood, plant fibers or plastics - and children's water and compote bottles, including items such as straws and spouts, can come off and be swallowed. The objective was to prevent the risk of suffocation and ingestion of small elements.

Although few anomalies were noted during visual and documentary checks, more than a third of the products targeted by the investigators were deemed non-compliant by the laboratory, more than half of which were declared dangerous.

21/09/2021

DGCCRF (Direction générale de la concurrence, de la consommation et de la répression des fraudes)

Non-food products: how far is it allowed to imitate a food? (in French)

Non-food products that go too far in the imitation of food, such as Candles in the shape of fruit, hamburgers in synthetic foam, cosmetic with a chocolate scent, etc.., can present risks of household accidents, especially for children.

The DGCCRF published a report which showed the restrictions on these kinds of products in several sectors such as cosmetics, decorations, household equipment and toys. The aim of the investigation was to control these everyday objects which bear too much resemblance to food.

29/07/2021

DGCCRF

(Direction générale de la concurrence, de la consommation et de la répression des fraudes)

Made in France claim

The origin of products is an essential criterion in the purchasing decision of French consumers and a major stake for the revival of the economy and the modernisation of French industry. Also, the DGCCRF conducted an investigation between 2019 and 2020, in order to control all claims on the origin of non-food products and in particular statements such as "made in France" or statements of local origin.

01/07/2021

German Federal Institute for Risk Assessment (BfR)

The update concerns BfR Recommendations on food contact materials for rubber:

  • XXI: Commodities based on natural and synthetic rubber
  • XXI/1: Commodities based on natural and synthetic rubber in contact with food
  • XXI/2: Special consumer goods made of natural and synthetic rubber and of lattices made of natural and synthetic rubber (formerly special category)​

 

Guide for the Protocol between Canada and European Union

 

On 1st September 2021, The European Commission published the following notice about the Canada Comprehensive Economic and Trade Agreement (CETA):

 

Commission Notice Implementation Guide for the Protocol to the CETA Agreement between Canada, the European Union and its Member States regarding the mutual acceptance of the results of conformity assessment (2021/C 351/01).

 

The aim is to facilitate the implementation of the Protocol and it provides practical guidance on the actions and steps to be taken by accreditation bodies and authorities.

 

The document focuses on the steps that the European Union and its Member States need to undertake when they carry out conformity assessment according to EU and Canadian legislation.

 

The Directive 2009/48/EC: Safety of Toys is one of the listed harmonised European legislation in the Protocol. The EU and Canada will consult with each other to broaden the legislations giving priority to the following product groups:

 

  • Medical devices including accessories
  • Personal protective equipment
  • Pressure equipment, including vessels, piping, accessories and assemblies
  • Appliances burning gaseous fuels, including related fittings
  • Rail systems, subsystems and interoperability constituents
  • Equipment placed on board a ship

 

Standards updates

 

Please see the below table summarising 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 17406:2020 +A1:2021

Classification for bicycles usage

31/03/2022


EN 17406:2020/prA1

EN 17406:2020

EN 913:2018+A1:2021

Gymnastic equipment - General safety requirements and test methods

31/03/2022


EN 913:2018/prA1

EN 913:2018

EN ISO 20957-2:2021

Stationary training equipment - Part 2: Strength training equipment, additional specific safety requirements and test methods (ISO 20957-2:2020)

2021-12-31

EN 957-2:2003

EN ISO 20957-7:2021

Stationary training equipment - Part 7: Rowing equipment, additional specific safety requirements and test methods (ISO 20957-7:2020)

2021-12-31

EN 957-7:1998

 

France

 

New extended producer responsibility sections in the environmental code

 

On 23rd September 2021, Decree No. 2021-1213 was published, relating to extended producer responsibility channels for toys, sports and leisure articles, and DIY and garden articles.

 

The decree introduces three new sections into the environmental code relating to these categories of products provided for by law as of February 10, 2020 on the fight against waste and the circular economy and they will be fully operational from January 1, 2022.

 

From this date, natural or legal persons who place these products on the national market will be required to contribute or provide for the collection, reuse, repair and recycling of waste from these products. The decree clarifies the scope of these three sectors by defining toys, sports and leisure articles, and DIY and garden articles, as well as the producers covered by these provisions.

 

To view the official publication, visit the Légifrance website here.

 

The identification of endocrine disruptors in consumer products

 

On 25th August 2021, The French Authorities published the following Decree related to law AGEC (the fight against waste and the circular economy):

 

Decree n ° 2021-1110 of 23 August 2021 relating to the provision of information allowing the identification of endocrine disruptors in a product.

 

The aim of the decree is the provision of information to identify endocrine disruptors in a product placed on the market.  Thus, it requires that any person placing on the market products containing substances exhibiting endocrine disrupting properties according to the ANSES publishes a list of these products and the substances that each of them contains. This publication will be carried out in an open format allowing collaborative platforms to exploit this information and thus better inform consumers. The obligation relating to the provision of information allowing the identification of endocrine disruptors in a product placed on the market applies no later than six months after the publication of the order fixing the list of substances with disrupting properties.

 

US

 

Direct final rule for safety standards for gates and enclosures

 

On 28th September 2021, the U.S. Consumer Product Safety Commission (CPSC) published a direct final rule updates which clarifies the mandatory standard for gates and enclosures.

 

It incorporates the voluntary standard ASTM F1004-21 in 16 CFR part 1239.

 

This standard includes performance requirements, test methods, and labelling and instructions for use requirements to address the hazards to infants and children associated with this kind of products.

 

The rule will be effective from 2nd January 2022, unless the Commission receives a significant adverse comment by October 28, 2021. In such case, it will be withdrawn.

 

For more information, consult the federal register publication here.

 

Flammability standards for residential upholstered furniture 2008 is withdrawal

 

On 16th September 2021, the Consumer Product Safety Commission (CPSC) published a document which indicated that its proposed rule on flammability standards for residential upholstered furniture that was published March 4, 2008 in the Federal Register has been withdrawn. This rule is no longer active because it has been superseded by the COVID-19 Regulatory Relief and Work From Home Safety Act. The COVID-19 Act establishes the regulatory text of the California standard, TB 117-2013, as the mandatory federal flammability standard for upholstered furniture and sets forth the statutory requirements. The ruling went into effect on June 25, 2021, and applies to all upholstered furniture manufactured, imported, or reupholstered on or after that date. However, the new labeling requirement will go into effect on June 25, 2022.

 

For more information, consult the official publication here.

 

US | Oregon

 

“Unit” clarification for application of the Toxic Free Kids Act

 

On 26th August 2021, the Oregon health authority published the temporary administrative order with the aim to clarify the reporting of children’s products under the Toxic Free Kids Act.

 

The main point of the clarification is the “Unit” definition which has been defined as having the same meaning as “component part”. This point is important because the law requires reporting of the HPCCCH that are present in amounts greater than100 ppm (0.01 %). The authorities think that situation could arise where a HPCCCH might exceed this reporting limit in a component part of a product, but not in the entire product.

 

For more information, consult the official publication (PH 40-2021) here.

 

US | California

 

PFAS are already regulated in California for juvenile products

 

On 5th October 2021, the governor of the US state of California approved the Bill Nº 652 Product safety: juvenile products: chemicals: perfluoroalkyl and polyfluoroalkyl substances (PFAS). The aim is to regulate these substances in Juvenile products. The limit is at or above 100 ppm (total organic fluorine) in a product or product component.

 

This bill does not apply to the following products:

 

  • A children’s electronic product, including, but not limited to, a personal computer, audio and video equipment, calculator, wireless phone, game console, handheld device incorporating a video screen, or any associated peripheral such as a mouse, keyboard, power supply unit, or power cord.
  • A medical device.
  • An internal component of a juvenile product that would not come into direct contact with a child’s skin or mouth during reasonably foreseeable use and abuse of the product.
  • An adult mattress.

It will be effective from 1st July 2023.

 

For more information, consult the official publication here.

 

New requirements for recycling claims

 

On 5th October 2021, California Governor Gavin Newsom signed Senate Bill 343 -Environmental advertising: recycling symbol: recyclability: products and packaging. The aim is to provide accurate and useful information about the environmental impact of plastic products.

 

This bill will prohibit a person from offering, selling, distributing, or importing into the state any product or packaging for which a deceptive or misleading claim is made about the recyclability of the product or packaging and will also provide the requirements for information and documentation for the use of the term “recyclable,” the use of a chasing arrows recycling symbol, or other representation that advises consumers to recycle a consumer good.

 

Standards updates

 

The table below summarises some recent ASTM standards updates:

 

Reference

Title

ASTM F2933 - 21a

Standard Consumer Safety Specification for Crib Mattresses

ASTM F1951 - 21

Standard Specification for Determination of Accessibility of Surface Systems Under and Around Playground Equipment

ASTM F3512 - 21

Standard Test Method for Evaluating Wind Safety and Durability of Market Umbrellas

 

China

 

China released GB Standards

 

Recently, the State Administration for Market Regulation (SAMR) and the Standardization Administration of the People’s Republic of China (SAC) jointly published announcement no.09 and 12 (in Chinese) of 2021 to approve and release a batch of GB standards which are closely related to our industries.

 

The below table listed some of these standards (non-exhaustive list):

 

Furniture

GB/T 40904-2021

Methods for the determination of prohibited substances in furniture products and related materials—Azo dyes

Initial

2022-05-01

GB/T 40906-2021

Methods for the determination of prohibited substances in furniture products and related materials—Certain phthalate esters

Initial

2022-05-01

GB/T 40907-2021

Methods for the determination of prohibited substances in furniture products and related materials—2,4-diaminotoluene and 4,4'-methylenedianiline

Initial

2022-05-01

GB/T 40908-2021

Methods for the determination of prohibited substances in furniture products and related materials—Flame retardants

Initial

2022-05-01

GB/T 40971-2021

Methods for the determination of prohibited substance in furniture products and related materials—Polycyclic aromatic hydrocarbons

Initial

2022-05-01

Jewellery

GB/T 11888-2021

Jewellery—Ring-size—Definition, measurement and designation

GB/T 11888-2014

2022-05-01

GB/T 17832-2021

Silver jewellery alloys—Determination of silver—Volumetric (potentiometric) method using potassium bromide

GB/T 17832-2008

2022-05-01

GB/T 18996-2021

Silver jewellery alloys—Determination of silver—Volumetric(potentiometric) method using sodium chloride or potassium chloride

GB/T 18996-2003

2022-05-01

 

National Standard for furniture

 

On 16th August 2021, the State Administration for Market Regulation (Standardisation Administration of the P.R.C.) of China notified the World Trade Organisation of the following national standards:

 

Reference

Title

G/TBT/N/CHN/1617

National Standard of the P.R.C, Technical Specification for Safety of Furniture Structure

It specifies the general safety requirements for furniture structures and the structural safety requirements for specific products. It is applicable to furniture products except for infant and children furniture

G/TBT/N/CHN/1618

National Standard of the P.R.C., Limit of Harmful Substances of Furniture

It specifies the terms and definitions, requirements, test methods and judgement inspection results for harmful substances in furniture. This standard is applicable to all types of furniture products.

G/TBT/N/CHN/1623

National Standard of the P.R.C., Technical Specifications for the Safety of Infants' and Children's Furniture

It specifies the general safety requirements for infants' furniture and children's furniture and the safety requirements for specific products. This document is applicable to infants' furniture and children's furniture.

 

Brazil

 

New requirements for Baby Bottles

 

On 24th August 2021, Inmetro (Brazil’s Ministry of Economy/National Institute of Metrology, Quality and Technology) published an amendment on the Ordinance No. 216 related to Baby Bottles.

 

The Ordinance No. 2013 was published on 5th May 2021 and came into force in June 2021.

 

Its aim is establishing criteria, requirements and procedures to assess the conformity of bottles and teats, under a health surveillance regime, with a safety focus, through the certification mechanism, aimed at preventing consumption accidents. The conformity assessment must be carried out by a Product Certification Body, established in Brazil and accredited by Inmetro.

 

The complementary documents for the conformity assessment requirements were changed with the amendment published in August. The list of updated complementary documents are:

 

Reference

Title

Law No. 11,265, of January 3, 2006

Regulates the sale of foods for infants and children of early childhood and also products related to childcare.

RDC Resolution No. 56, of November 16, 2012, or substitute

It establishes the positive list of monomers, other starters and polymers authorized for the preparation of plastic containers and equipment in contact with food, the prohibition of the use of Bisphenol A in baby bottles and other measures.

Resolution RDC No. 123, of June 19, 2001, or substitute

Technical regulations on elastomeric containers and equipment in contact with food.

Resolution RDC No. 51, of November 26, 2010, or substitute

Provides for the regulation of migration in plastic materials, packaging and equipment intended to come into contact with food.

RDC Resolution No. 52, of November 26, 2010, or substitute

Provides for the regulation of colorants in plastic containers and equipment intended to be in contact with food.

Resolution RDC No. 17, of March 17, 2008, or substitute

Provides the positive list of additives for plastic materials intended for the preparation of packaging and equipment in contact with food.

Resolution RDC No. 221, of August 5, 2002, or substitute

Provides for the regulation of pacifiers, teats, baby bottles and teat protectors

Anvisa Resolution No. 105, of May 19, 1999, or substitutes

Provides for the regulation of general provisions for plastic containers and equipment in contact with food.

Ordinance No. 27, of March 18, 1996

Provides for the regulation of glass and ceramic containers in contact with food.

Inmetro ordinance in force

General requirements for product certification - RGCP.

ABNT NBR 13793: 2012

Safety of baby bottles and bottle teats

ABNT NBR 5426: 1989

Sampling plans and procedures for inspection by attributes.

 

South Korea

 

DIBP added in the phthalates restriction list for children’s product

 

On 19th July 2021, the South Korea’s Ministry of Trade, Industry and Energy (MOTIE) published the notice No. 2021-132 which indicated that Di-isodecyl phthalate (DIBP - CAS number 68515-49-1/26761-40-0) has been added to the restricted phthalates list (DEHP, DBP,BBP, DINP, DIDP and DnOP) under the Common Safety Standards for Children’s Products (CSSCP). It will become effective on 1st January of 2022.

 

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/CHL/575

Chile

Draft Regulation on the safety of products used by children

It establishes the safety requirements to be met by products used by children, which are imported, distributed or marketed in the country, regarding flammability and physical, mechanical, chemical and electromagnetic risks.

G/TBT/N/CHN/1619

China

National Standard of the P.R.C., Limits of Hazardous Substances for Musical Instruments

It specifies the terminology, definitions and classification related to musical instruments, musical instrument accessories and musical instrument packages placed indoors, and specifies the requirements, test methods, inspection rules and packaging marks of the limits of hazardous substances to human body for musical instruments, musical instrument accessories and musical instrument packages placed indoors.

G/TBT/N/CHN/1620

China

General Requirements for the Safety of Indoor Stationary Training Equipment

It specifies the safety requirements of indoor stationary training equipment. This document is applicable to all stationary fitness equipment defined in 3.1. It includes the fixed fitness equipment (Class S and Class I) used in various group training places controlled and managed by owners (persons with legal liability), such as sports associations, educational institutions, hotels, gymnasiums, clubs, rehabilitation centers and studios; It also includes household stationary fitness equipment (Class H) and other types of stationary fitness equipment, including electric driven stationary fitness equipment defined in 3.1.

 

Technical publications

 

Please find below a table summarising recent technical publications (non-exhaustive):

 

Date

Entity

Comments

20/09/2021

CMA (UK’s Competition and Market Authority)

Guidance Green claims code: making environmental claims

The purpose of this guidance is to help businesses understand and comply with their existing obligations under consumer protection law when making environmental claims.

01/09/2021

KATS

(Korean Agency for Technology and Standards)

Results of Safety Investigation for Children's Products (in Korean)

KATS published the results of the 2021 safety investigation plan about toys (Children’s toys, educational toys and school supplies). The hazardous chemicals  and durability was checked for this kind of product.

 

Product Recalls / Alerts

 

Below you will find a monthly summary table of product recalls and alerts in Europe (Source “RAPEX” and “RASFF”) and the U.S. (Source “CPSC”).

 

Europe

 

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

 

The following 27 alerts regarding Childcare articles, equipment and toys were reported, between week 38 and week 41 of 2021.

 

Type of Risk

Number of alerts

Notes

Chemical

3

Plastic dolls

The toy contains an excessive amount of bis(2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DNOP) and dibutyl phthalate (DBP). It does not comply with Toy Safety Directive nor with REACH.

1

Fingerpaint

The yellow and red colours contain an excessive quantity of the preservative 2-methylisothiazoline-3(2)H-on.

It does not comply with the requirements of the Toy Safety Directive and EN 71-10 and EN 71-11.

1

Inflatable swim ring

The plastic material of the product (swim ring and inflation valve) contains an excessive amount of bis(2-ethylhexyl) phthalate (DEHP).

It does not comply with the REACH Regulation.

3

Toy Slime

The migration of boron from the toy slime is too high.

It does not comply with the requirements of the Toy Safety Directive and EN 71-3.

1

Felt pens

The grey felt pen contains an excessive amount of the preservatives 2-Methyl-4-isothiazolin-3-one (MI) and 5-chloro-2-methyl-4-isothiazolin-3-one (CMI).

It does not fulfil the requirements of the Toy Safety Directive.

Chemical, Choking

1

Plastic toy

The battery compartment can be easily opened, leaving the button cell batteries accessible.

It does not comply with the requirements of the Toy Safety Directive and EN 62115.

Chemical, Environment

1

Battery toy piano

The solders in the toy contain lead and cadmium in concentrations above limit values.

It does not comply with the Commission Directive on the restriction of the use of certain  hazardous substances in electrical and electronic equipment (RoHS 2 Directive).

Choking

2

Soft toys

Small parts (the zipper handle) can easily detach from the toy. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

5

Soft toys

Due to the weakness of certain seams, the fibrous stuffing material of the toy is easily accessible. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

1

Soother holder

In case of impact, the wooden shield of the product may easily break generating small parts. It does not comply with the General Product Safety Directive and with EN 12586.

1

Soft pony

Due to the weakness of certain seams on the head of the toy, small parts (the mane of the pony) are easily detachable. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

1

Wooden puzzle – airplane

Small parts may easily detach from the toy.

It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

Choking, Injuries

1

Magnetic toy set

The toy is made of small parts (balls) with a high magnetic flux.

It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

Damage to sight

1

Crystal Creations Hair Accessories

Due to inadequate warning on the packaging and inadequate instructions on how to use the glue applicator, glue might come in contact with the user’s eye, causing eye injuries. It does not comply with the CLP Regulation nor with the requirements of the Toy Safety Directive.

Environment

1

Battery-operated toy piano

The solders of the toy contain an excessive amount of lead.

It does not comply with the requirements of the Directive 2011/65/EU on the restriction of hazardous substances (RoHS) and the relevant European standard EN 62321-5.

Injuries

1

Baby pushchair

The pushchair is not stable enough and the seat restraint system might break.

It does not comply with the General Product Safety Directive and  EN 1888-1.

1

Baby stroller

The handlebar is not resistant enough and may break causing a loss of control of the stroller.

It does not comply with the General Product Safety Directive and  EN 1888-1.

1

Doll stroller

The pushchair has only one safety lock and is not sufficiently resistant to load.

It does not comply with the requirements of the Toy Safety Directive and EN 71-1

 

The following 23 alerts regarding Childcare articles, equipment and toys were reported, between week 34 and week 37 of 2021.

 

Type of Risk

Number of alerts

Notes

Burns

1

Fancy-dress mask: The mask is easily flammable and the flame propagation is too high. It does not comply with the Toy Safety Directive and EN 71-2.

Chemical

5

Plastic dolls: The toy contains an excessive amount of bis(2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DNOP) and dibutyl phthalate (DBP). It does not comply with Toy Safety Directive nor with REACH.

1

Toy putty (Slime)

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

1

Toy pool:  It contains an excessive amount of diisodecyl phthalate (DIDP). They do not comply with the REACH Regulation.

1

Ball game: The plastic material of the bolls contains bisphenol A. It does not comply with the Toy Safety Directive.

Choking

1

Plush toy: Small parts (the zipper handle) can easily detach from the toy. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

1

Toy bow and arrows: The arrows' suction cups can be easily detached. If a child puts them in the mouth, the suction cups could detach and obstruct the airways. It does not comply with the Toy Safety Directive and with EN 71-1.

1

Pacifier clip: It can easily break releasing small parts. It does not comply with the General Product Safety Directive and with EN 12586.

1

Wooden Carousel: Small parts (the buttons) can easily detach from the toy. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

1

Bath toy set: Small plastic parts (squeaking element) may easily detach from the toy. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

1

Set of soft toys with key ring: Small parts (a plastic eye from the doll and the ring of the bear-key ring) may easily detach from the toys. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

1

Soft toy: A small part (plastic bow) may easily detach from the toy. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

1

Whistle toy: The toy is too small. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

Cuts

1

Playground swing for two children: The product has protruding edges which are not protected. This can cause serious cuts on any part of the body which they come into contact with.  It does not comply with the General Product Safety Directive and the EN 1176.

Damage to hearing

1

Toy telephone: The sound level produced by the toy is too high. It does not comply with the requirements of the Toy Safety Directive and EN 71-1.

Injuries

1

Trampoline sprinkler: The product lacks instructions for use and a warning label to warn against using the trampoline in wet conditions. It does not comply with the Toy Safety Directive and the relevant European standard 71-1, 2 and 3.

1

Children's car seat: In case of a frontal crash, the child car seat (CRS) may not give the protection against head displacement as required. As a consequence, the child could be injured. Furthermore, the mass group in the manual does not correspond to the one indicated in the label and for which the product is intended. It does not comply with Regulation UN/ECE N. 44-04.

1

Toy rocking horse: The toy doesn't have the required movement limiters. This causes that the user of the toy is not held within the extreme of the bow. It does not comply with the Toy Safety Directive and EN 71-1.

1

 Space expedition toy set: The battery compartment of the torch of the set can be easily opened, leaving batteries accessible. It does not comply with the requirements of the Toy Safety Directive and with the relevant European standard EN 62115.

1

Plastic toy

The toy is elastic and can be considerably stretched during use. A child could swing the toy around the head and twist it around the neck, causing strangulation. It does not comply with the Toy Safety Directive and EN 71-1.

Microbiological

1

Finger paints: T Contamination with Pseudomonas aeruginosa has been detected in the yellow and the blue paints. It does not comply with the requirements of the Toy Safety Directive.

 

The following 7 alerts regarding hardgoods/ miscellaneous goods were reported, between week 38 and week 41 of 2021.

 

Type of Risk

Number of alerts

Notes

Chemicals

2

Dog lead

The leather in the product contains an excessive amount of chromium VI. It does not comply with the REACH Regulation.

1

Piercing jewellery

The product contains an excessive amount of cadmium.

It does not comply with the REACH Regulation.

1

Plastic hooks

The product contains an excessive amount of bis(2-ethylhexyl) phthalate (DEHP) The product contains an excessive amount of bis(2-ethylhexyl) phthalate (DEHP). It does not comply with the REACH Regulation.

1

Necklace

The product releases an excessive quantity of nickel.

It does not comply with the REACH Regulation.

1

Bracelets

he product contains an excessive amount of cadmium.

It does not comply with the REACH Regulation.

Injuries

1

Folding stool

The stool has no locking device and the user can consequently suffer injuries with the clamping points.

It does not comply with the requirements of the General Product Safety Directive nor with EN 12520.

 

The following 9 alerts regarding hardgoods/ miscellaneous goods were reported, between week 34 and week 37 of 2021.

 

Type of Risk

Number of alerts

Notes

Burns, fire

2

Charcoal barbecue: The horizontal plan of the barbeque becomes too hot,reaching a temperature of 87 degrees above the ambient temperature. It does not comply with the General Product Safety Directive and EN 1860-1.

Burns, Fire, Injuries

1

Self-balancing scooter (hoverboard): The battery does not have a device that monitors the cells temperature, hence it may overheat during charging, and the hoverboard cover may ignite. The product may cause a fire and the user may suffer burns. In addition, the power cords, which are exposed to movement between the two motors, are routed through a steel pipe with sharp edges at both ends. During the life of the product, the insulation of the power cords can be damaged by the sharp edges, the battery may short-circuit and explode during use.

It does not comply with EN 60335 and EN 62133.

Chemicals

1

Pencil case: The pencil case contains di(2-etylhexyl) phthalate (DEHP). It does not comply with the REACH Regulation.

1

Anklet: The product contains excessive amounts of cadmium. It does not comply with the REACH Regulation.

1

Wristwatch: The product releases an excessive amount of nickel. It does not comply with the REACH Regulation.

1

Earrings: The product contains an excessive amount of lead. amount of nickel. It does not comply with the REACH Regulation.

Injuries, Strangulation

1

Duvet and Pillowcase Set: The trim of the bedding may become detached and form a loop in which a limp or a body part of the user may become trapped. It does not comply with the General Product Safety Directive.

 

RASFF (European Commission Rapid Alert System for Food and Feed - Alerts reported by EU national authorities).

 

The following 6 alerts regarding Food Contact Materials related to children's tableware were reported from the 21st September 2021 to the 20th October of 2021.

 

Product

Substance / Hazard

Feeding set for children

Food Contact Material - Melamine Formaldehyde resin 40-45%, Wood Pulp 20-25%, Bamboo powder 15-30% - the product does not comply with the Commission Regulation (EC) No. 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food

RASFF - Notification detail

Dinner set for children and a tray

Unauthorised use of melamine and bamboo fiber in plastic

RASFF - Notification detail


Dish, bowl, tray and glass

Unauthorised use of bamboo and plastics in tableware from China

RASFF - Notification detail

Baby nursing bottles

Migration of dibutyl phtalate (DBP) in baby nursing bottles

RASFF - Notification detail


Bamboo mix lunch box

Bamboo not approved as an additive in plastic food contact articles

RASFF - Notification detail

Lunchboxes

Food Contact Material Lunch box natural M P18 containing 57% polypropylene and 43% bioingredient (rice husk) - due to the presence of rice hulls in the composition, the product does not comply with the Commission Regulation (EC) No. 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food

RASFF - Notification detail

 

The following 6 alerts regarding Food Contact Materials related to children's tableware were reported from the 21st August 2021 to the 20th September of 2021.

 

Product

Substance / Hazard

5 piece bamboo tableware set

Unauthorised use of bamboo in bamboo fibres, maize starch and melamine children's tableware from China, dispatched from Taiwan

RASFF - Notification detail

5 piece set children's bamboo fiber tableware

Unauthorised use of bamboo in bamboo fibres, cardboard and melamine children's tableware offered online for sale

RASFF - Notification detail

Children bamboo tableware

Unauthorised use of bamboo in Children's tableware offered online for sale

RASFF - Notification detail

Children's bamboo tableware

Unauthorised use of bamboo in bamboo fibres and melamine children's tableware offered online for sale

RASFF - Notification detail

Children's tableware set, 5 pieces

Unauthorised use of bamboo in children's tableware set offered online for sale

RASFF - Notification detail

Children's tableware set

Unauthorised use of bamboo in children's tableware set offered online for sale

RASFF - Notification detail

 

US

 

From the 21st September 2021 to the 20th October of 2021, CPSC (Consumer Product Safety Commission) published the following 2 recalls: 2 recalls regarding Childcare and children’s products.

 

Hazard

Number of alerts

Notes

Fall and injury

1

Strollers

The stroller’s front wheel bearing can fail or detach.

suffocate

1

Newborn Loungers

Infants can suffocate if they roll, move, or are placed on the lounger in a position that obstructs breathing, or roll off the lounger onto an external surface, such as an adult pillow or soft bedding that obstructs breathing.

 

2 recalls regarding furniture

 

Type of Risk

Number of alerts

Notes

Fall

1

Chair

It can break or collapse when weight is applied

Fall and injury

1

Stools

It can break during use

 

From the 21st August 2021 to the 20th September of 2021, CPSC (Consumer Product Safety Commission) published the following recalls: 7 recalls regarding Childcare and children’s products.

 

Hazard

Number of alerts

Notes

Skin irritation

1

Scent Stamper Pens: The purple Scent Stamper Pen has elevated levels of benzyl alcohol.

Drowning

1

Infant Bath Seats: The bath seats fail to meet the federal safety standard for infant bath seats, including requirements for stability and leg openings, and can tip over while in use

Choking

2

Wooden tray puzzles: The octopus and elephant puzzle pieces can break.

Children’s eating utensils: The handle of the Cutie Spoovel utensil can break off releasing small parts.

Injuries

1

Bike Helmets: The bicycle helmets do not comply with the U.S. CPSC federal safety standard for bicycle helmets.

Fall

1

StepUp Sidekick Learning Towers: The storage tray with cup holders and step can come loose from the tower.

Chemical

1

Children’s Shaving Kits: The brown trim of the shaving kit bags contains levels of a regulated phthalate that exceed the prohibition of specific phthalates. Banned phthalates are toxic if ingested by young children.

 

4 recalls regarding furniture

 

Type of Risk

Number of alerts

Notes

Laceration and  pinching hazard

1

True Living Sling Lounger: The recalled loungers can collapse unexpectedly, posing an amputation, laceration and  pinching hazard if finger gets caught in the metal folding joints.

Fall and injury hazards

2

Swivel Counter Stools: The counter stools can break or collapse. 

Chair: The counter stools can break or collapse, posing fall and injury hazards.  

Fall hazard

1

Teak shower benches: The shower bench can collapse during use, posing a fall hazard to the user.

 

 

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

 

New European recommendations for PPE’s market surveillance

 

On 2nd September 2021, European Commission published the following recommendation related to personal protective equipment (PPE):

 

RECOMMENDATIONS COMMISSION RECOMMENDATION (EU) 2021/1433 of 1 September 2021 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat

 

 It adopts new points which the authorities must follow and comply with in market surveillance procedures of this type of goods.

 

Below a summary table with the recommended points:

 

Market surveillance procedures

Point

Procedure

1

From 1st October 2021, Market surveillance authorities should no longer authorise PPE which are not according with Article 19 of Regulation (EU) 2016/425.

After 1st October 2021, PPE in accordance with points 7 or 8 of Commission Recommendation (EU) 2020/403 cannot be placed on the Union market

2

Medical devices, which are not in accordance with Article 52 of Regulation (EU) 2017/745, will be able to be authorised to be made available on the Union Market, only by following the procedure for derogations from the conformity assessment procedures laid down in Article 59 of Regulation (EU) 2017/745.

3

PPE or medical devices, which have been authorised in accordance with the mechanisms described in point 7 or 8 of Commission Recommendation (EU) 2020/403, shall only be made available until 31 May 2022.

By means of exception, any such PPE or medical device, which is part of existing stocks may be made available until such stocks are fully exhausted but in any event no later than 31 July 2022.

4

From 1 August 2022, PPE or medical devices have to be in according with  Article 19 of Regulation (EU) 2016/425 or Article 52 of Regulation (EU) 2017/745 and bear a CE marking, in accordance with Article 17 of Regulation (EU) 2016/425 or Article 20 of Regulation (EU) 2017/745, unless, in the case of medical devices, specific derogations from the conformity assessment procedure have been authorised by Member States according to Article 59 of Regulation (EU) 2017/745.

5

A non-compliant PPE product or medical device have to be informed immediately the Commission and the other Member States.

For PPE through the Information and Communication System for Market Surveillance (ICSMS) and notify them in the rapid alert system for dangerous non-food products (Safety Gate/RAPEX).

6

A non-compliant PPE product or medical device

Market surveillance authorities should immediately set in motion the relevant procedures laid down in Chapter VI of Regulation (EU) 2016/425 or Chapter VII of Regulation (EU) 2017/745.

 

For more information, consult the official publicationhere.

 

Spain

 

Guidance for the manufacturing and selection of masks

 

The Ministry of Industry, Commerce and Tourism has issue updated UNE specifications for hygienic masks. The following is a list of recent publications:

 

 

Product Recalls / Alerts

 

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

 

Europe

 

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

 

The following 8 alerts regarding Personal Protective equipment were reported between week 34 and week 41 of 2021.

 

Type of Risk

Number of alerts

Notes

Health risk/ other

7

Particle filter mask

The particle/filter retention of the material is insufficient.

It does not comply with the Personal Protective Equipment Regulation and with EN 149.

1

Particle filter mask

The product bears a CE marking 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.

 

US

 

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