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Consumer Products | Bimonthly bulletin | March 2021

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Eurofins newsflash Consumer Products

 

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

 

 

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Europe

 

Over five million notifications received in the SCIP database for harmful chemicals in products

 

As of 5 January 2021, under the Waste Framework Directive, companies are obliged to submit data on Substances of Very High Concern (SVHC). This concerns all companies placing articles on the EU market containing SVHCs on the Candidate list in a concentration above 0.1% weight by weight (w/w) and quantities totaling over one tonne per year.

 

The database ensures that the information on articles containing SVHC on ECHA´s Candidate list is made available throughout the whole lifecycle of products and materials, including the waste stage, thereby contributing to a safer circular economy. Additionally, the increased transparency regarding hazardous chemicals in products will help consumers make more informed choices.

 

Companies have already submitted more than five million notifications to the database and this is expected to continue. The information in the database will be made available to waste operators and consumers.

 

To support companies in ensuring successful SCIP notifications, it is recommended that when submitting notification, the Candidate list reference substances package provided by ECHA is used. This can be imported into your own IUCLID instances. The ECHA has published manuals, webinars and tips for successful submissions.

 

More information is available on ECHA´s website.

 

Almost 350,000 notifications submitted in harmonised format and unique formula identifiers (UFIs)

 

Almost 350,000 notifications were submitted by the year end via the ECHA Submission portal.

 

From 1 January 2021, importers and downstream users placing hazardous mixtures on the market are obligated to notify their mixtures in a harmonised format and unique formula identifiers (UFIs) must be included on mixture labels.

 

 

If you need to notify your mixtures in the new harmonised format, tools and step-by-step support are available on ECHA´s website.

 

New update of Candidate list of Substances of Very High Concern (SVHCs)

 

On 19th January 2021, the ECHA (European Chemicals Agency) released the new Candidate list of SVHCs. With the addition of 2 new substances, the current list of SVHCs contains 211 substances.

 

Below the table with the last substances included:

 

Substance name

EC number

CAS number

Reason for inclusion

1

Bis(2-(2-methoxyethoxy)ethyl)ether

205-594-7

143-24-8

Toxic for reproduction
(Article 57 (c)) 

2

Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety

-

-

Toxic for reproduction
(Article 57 (c)) 

 

Click here to read the official news from ECHA’s website.

 

Proposal to list methoxychlor as Persistent Organic Pollutant (POP)

 

The United Nations' Persistent Organic Pollutants Review Committee adopted the risk profile for methoxychlor. Afterwards, the Committee will prepare the draft risk management evaluation and the substance may then be listed under the Stockholm Convention as a Persistent Organic Pollutant (POP). This would result in either a worldwide elimination or a severe restriction of its production and use.

 

Methoxychlor is an organochlorine pesticide originally developed as a replacement for DDT. The EU banned production of methoxychlor in 2002, with some member states having put bans in place prior to this.

 

ECHA supports the Commission and the member states in identifying new POPs and carries out public consultations during the identification process for substances that have been proposed by the Commission.

 

More information is available here.

 

ECHA updates the list of restricted substances under REACH Annex XVII

 

On 16th December 2020, the European Union (EU) published Regulation (EU) No 2020/2096, which updated Annex XVII of REACH. Summarised below are the main updates on the restricted substances included:

 

Entry number

Substance name

EC number

CAS number

Reason for inclusion

Start applying date

3

Liquid substances or mixtures fulfilling the criteria for some hazard classes or categories(1) set out in Annex I to Regulation (EC) No 1272/2008

-

-

References to labelling with R65 in paragraphs 3 and 5 that were set out according to the repealed Directive 67/548/EEC (DSD) has been deleted  and therefore substitute by H304 to align it with Regulation (EC) No 1272/2008 (CLP)

05/01/2021

Paragraphs 6 and 7 were deleted since ECHA concluded that there is no need to propose an amendment of this restriction

Entry 22

Pentachlorophenol and its salts and esters

201-778-6 and its salts and esters

87-86-5

Deleted from Annex XVII to REACH since more severe restrictions are laid down for these substances in POP Recast Regulation (EU) 2019/1021 on Persistent Organic Pollutants

05/01/2021

Entry 67

Bis(pentabromophenyl)ether (decabromodiphenyl ether; decaBDE)

214-604-9

1163-19-5

Entry 68

Perfluorooctanoic acid (PFOA) and its salts

206-397-9

335-67-1

04/07/2020

Entries 28, 29 and 30

Substances which are classified as carcinogen, germ cell mutagen and reproductive toxicant categories 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 and are listed in Appendices 1 or 2, 3 or 4 and 5 or 6, respectively.

-

-

For Entry 28:

  • New entries are inserted in Appendix 2(2) to align them with CLP Regulation

For Entry 30:

  • New entry is inserted in Appendix 52 to align it with CLP Regulation
  • New entries are inserted in Appendix 62 to align them with CLP Regulation

05/07/2021 or 01/10/2021 depending on the new substances listed in the specific Appendices.

A new exemption is added in Point (f): devices covered by Regulation (EU) 2017/745

Medical devices are exempted from the restriction since it is covered by Regulation (EU) 2017/745  to avoid double regulation

05/01/2021

For Entry 28:

  • The titles of Appendix 1 and 2 are replaced by the following respectively: ‘Entry 28 – Carcinogens: Category 1A’ and ‘Entry 28 – Carcinogens: Category 1B’ according to CLP Regulation

For Entry 29:

  • The titles of Appendix 3 and 4 are replaced by the following respectively: ‘Entry 29 – Germ cell mutagens: Category 1 A’ and ‘Entry 29 – Germ cell mutagens: Category 1 B’ according to CLP Regulation

For Entry 30:

  • The titles of Appendix 5 and 6 are replaced by the following respectively: ‘Entry 30 – Reproductive toxicants: Category 1 A’ and ‘Entry 30 – Reproductive toxicants: Category 1 B’ according to CLP

Entry 43

Azocolourants and Azodyes

-

-

More up-to-date testing methods for azocolourants according to table for Appendix 10 below are included

05/01/2021

Entry 46

(a) Nonylphenol

246-672-0

25154-52-3

References to CAS number and EC numbers in paragraph (a) of column 1 are deleted in order to cover all isomers by this entry

05/01/2021

 

(1) For any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: (a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; (c) hazard class 4.1; (d) hazard class 5.1.

 

(2) Substances classified as CMR and listed in Appendices 1 to 6 to that Annex and of mixtures containing such substances above specified concentrations shall be prohibited to place on the market and use for supply to the general public.

 

Appendix 10

Entry 43 – Azocolourants – List of testing methods

European standardization organisation

Reference and title of the harmonized standard

Reference of the superseded standard

CEN

EN ISO 17234-1:2015 Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 1: Determination of certain aromatic amines derived from azo colorants

EN ISO 17234-1:2010

CEN

EN ISO 14362-1:2017 Textiles – Methods for determination of certain aromatic amines derived from azo colorants – Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres

EN 14362-1:2012

CEN

EN ISO 14362-3:2017 Textiles – Methods for determination of certain aromatic amines derived from azo colorants – Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene

EN 14362-3:2012

 

To view all updates, read the full publication here.

 

ECHA updates the list of testing methods for azocolourants (REACH Annex XVII)

 

On 16 December 2020, the European Union (EU) published the following amendment:

 

Commission Regulation (EU) 2020/2096 of 15 December 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants.

 

This regulation updated certain restricted liquid substances or mixtures, nonylphenol and testing methods for azocolourants under Annex XVII of REACH. The main points related to textile products are:

 

  • In entry 46 (Nonylphenol), the references to CAS number and EC number in paragraph (a) of column 1 are deleted
  • In Appendix 10, the table has been replaced by the following table:

 

Appendix 10

Entry 43 – Azocolourants – List of testing methods

European standardization organisation

Reference and title of the harmonized standard

Reference of the superseded standard

CEN

EN ISO 17234-1:2015 Leather – Chemical tests for the determination of certain azo colorants in dyed leathers – Part 1: Determination of certain aromatic amines derived from azo colorants

EN ISO 17234-1:2010

CEN

EN ISO 14362-1:2017 Textiles – Methods for determination of certain aromatic amines derived from azo colorants – Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres

EN 14362-1:2012

CEN

EN ISO 14362-3:2017 Textiles – Methods for determination of certain aromatic amines derived from azo colorants – Part 3: Detection of the use of certain azo colorants, which may release 4-aminoazobenzene

EN 14362-3:2012

 

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

09/02/2011

SCIP Notifications submitted through tools other than ECHA´s tools will not be included in the database of notifications and treated as not received as they do not fulfil obligations under the Waste Framework Directive Article 9(1)(i).

For more information, visit the ECHA’s website here

04/02/2021

ECHA has submitted a proposal to restrict the placing on the market and use of lead in ammunition (gunshots and bullets) and fishing tackle. The assessment will cover the use of lead in gunshot in terrains other than wetlands, bullets used both in wetlands and in terrains other than wetlands, as well as lead in fishing tackle.

Registry of restriction intentions until outcome can be viewed here

04/02/2021

SVHC 2020 Roadmap to address substances of very high concern has been completed. Currently known substances of very high concern have been identified and included in the Candidate list. The roadmap also aimed to efficiently identify new chemicals of concern based on a systematic screening of registered substances.

For more information, visit the ECHA’s website here

03/02/2021

The restriction on nonylphenol and its ethoxylates (Entry 46a under Annex XVII of REACH Regulation) in textiles started to apply on 3 February 2021 and aims to reduce emissions of nonyphenol ethoxylates (NPEs) to our environment.  NPEs concentrations equal to or greater than 0.01 % by weight are not allowed in any textile articles or their constituent parts. This does not apply to second-hand textile articles or new textile articles produced, without the use of NPE, exclusively from recycled textiles.

For more information, visit the ECHA’s website here

27/01/2021

The Forum´s ninth coordinated REACH enforcement project (REF-9) on authorisations obligations and on recovered substances started in January this year. The report on their results will be expected during 2022.

For more information, visit the ECHA’s website here

27/01/2021

Manual completeness checks performed by ECHA staff will be extended to chemical safety reports to ensure they contain all the elements required under REACH as of 1 March 2021. Registrants should, therefore, prepare for the changes, as registrations submitted before 1 March may no longer pass the completeness check.

 

27/01/2021

ECHA has submitted an intention to restrict the placing on the market, or use, of 2,4-dinitrotoluene (EC 204-450-0, CAS 121-14-2), as a substance in articles for supply to the general public or to professional workers in concentrations above 0.1 %. The restriction proposal is expected on 16 July 2021.

A call for evidence started on 27 January 2021 and will be open until 10 March 2021.

Registry of restriction intentions until outcome can be viewed here

27/01/2021

The European Commission has granted authorisation for pitch, coal tar, high temp. (EC 266-028-2; CAS 65996-93-2) for industrial use dedicated to high-performance civilian and military aerospace launchers with a review period expiry date on 4 October 2032.

For more information, visit the ECHA’s website here

20/01/2021

New and updated use maps elements published in the Use Maps Library for various sectors:

  • The European Council of the Paint, Printing Ink and Artists' Colours Industry (CEPE), published its use map package (use maps, SPERCs, SWEDs and SCEDs, including the Chesar file) for the first time;
  • Fertilizers Europe published a Chesar version of their use map and their SWEDs for the first time. The package also includes a “SWEDs and SUMIs guidance”;
  • The International Fragrance Association (IFRA), published its SPERCs for the first time; and
  • The European Solvents Industry group (ESIG), updated some of its use map Chesar files (for the low volatility low derived no-effect level (DNEL) and for the moderate volatility low DNEL).

Additionally, with the release of Chesar 3.6, several sectors (A.I.S.E., ECPA and I&P Europe) have updated their existing SWEDs and their Chesar file. The updated files are in line with the agreed harmonised set of conditions of use for workers and compatible with Chesar 3.6.

Use maps library can be consulted here

13/01/2021

The REACH restriction on substances in tattoo inks and permanent make up has been adopted and the final text is published in the Official Journal of the European Union.

For more information, visit the ECHA’s website here

13/01/2021

Guidance on authorization applications updated.

It clarifies the need for applicants to include substitution plans in their applications if the analysis of alternatives shows that suitable alternatives are available in the EU – although these alternatives might not be technically or economically feasible for the applicant.

Updated guidance on the preparation of an application for authorization can be viewed here

16/12/2020

The General Court issued a judgment in case T-207/18 dismissing in its entirety an action brought against ECHA’s decision to include bisphenol A in the Candidate list on the basis that it is a substance of a very high concern with endocrine-disrupting properties for the environment. The Court found that the applicant failed to demonstrate any legal or scientific error by ECHA rendering the identification as unlawful or implausible.

Judgement issued by the General Court can be viewed here

 

Other interesting links about REACH

 

 

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

2020/832/F

France

Decree on the provision of information to identify endocrine disruptors in a product.

This provision comes under the second national strategy on endocrine disruptors (SNPE2, published in September 2019) and aims to provide citizens with transparent information on the presence of substances with endocrine disrupting properties in products, in terms of substances, mixtures, articles and food. Endocrine disruptors are present in many everyday objects and have impacts on the environment and health (involved in many diseases).

 

UK

 

Approximately 20% of REACH registrations in the United Kingdom have not been transferred to the EU and will be revoked

 

REACH registrations in the United Kingdom had to be transferred to the EU before the end of the transition period on 31 December 2020. Unless the transfer of existing UK REACH registrations was initiated by the end of this transition period, existing REACH registrations will be revoked.

 

Approximately 20% of REACH registrations based in the United Kingdom have not been transferred to the EU and will be revoked.

 

Meanwhile, 80% started or completed the transfer of their registrations to the EU by the end of the transition period. To complete the ongoing transfers, EU companies receiving UK registration are reminded to accept the transfers as soon as possible. If the transfer is not finalised by 31 March 2021, the transfer will be cancelled, and the registration revoked. This means that the registrants will no longer be able to legally place the substance on the EU market.

 

The list of substances registered only by UK companies will be updated, as soon as the registration status will change, and available on ECHA´s website.

 

Recent updates regarding UK REACH

 

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

 

Summary  of the Most Recent Updates

Date

Subject

Link

26/02/2021

EU authorisation has been carried over (‘grandfathered’) into UK REACH.

GB-based holders of an existing EU Authorisation (Art 127F) must supply HSE with technical information relating to the authorization to enable the effective management and enforcement of the authorised substance. Deadline: 01 March 2021.

For more information visit HSE´s  website

26/02/2021

GB-based downstream users of an existing GB/EU27/EEEA-based authorisations can continue to use the substance in accordance with the conditions set out in the authorization.

GB-based downstream users must confirm to HSE some information according to Article 127H. Deadline: 01 March 2021.

For more information visit HSE´s  website

26/02/2021

GB-based producers and/or importers of articles who have previously notified to ECHA of SVHC in articles must provide HSE the previously provided information to ECHA.

This can be done via Comply with UK REACH IT system using the relevant template. Deadline: 01 March 2021.

For more information visit this website.

19/02/2021

UK REACH Agency statement on the use of independent scientific knowledge and advice (ISA) and transparency in carrying out functions survey.

The survey will close on 10th March 2021.

HSE survey is available here

 

Recent Updates regarding GB CLP

 

The below table includes a summary of the most recent updates (non-exhaustive) regarding GB CLP Regulation:

 

Summary  of the Most Recent Updates

Date

Subject

Link

08/02/2021

Consultation on harmonised classification and labelling of:

  • Hexyl salicylate (EC 228-408-6; CAS 6259-76-3)
  • Benthiavalicarb-isopropyl (ISO); isopropyl [(S)-1-{[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamate (EC -; CAS 177406-68-7)
  • 4-methylimidazole (EC 212-497-3; CAS 822-36-6)
  • 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol (EC 211-477-1; CAS 647-42-7)
  • 2,2'-[[3-methyl-4-[(4-nitrophenyl)azo]phenyl]imino]bisethanol (EC 221-665-5; CAS 3179-89-3)

The deadline for comments is 09 April 2021

Harmonised classification and labelling consultations can be viewed here.

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).

Scientific and technical information should be submitted directly to ECHA using their commenting website and it will be published on its website.

If you are likely to be affected by any of the C&L proposals, directly submit information to HSE at GBCLP.GBMCL@hse.gov.uk

 

U.S.

 

Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h)

 

On 6 January 2021, The Daily Journal of the United States Government published rules on the Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h) of the Toxic Substances Control Act (TSCA). The US Environmental Protection Agency (EPA) prohibits the manufacture, import, processing, and/or distribution of, among others, the following substances, with the aim of reducing their exposure to humans and the environment.

 

It became effective from 5 February 2021. To read the official publication, click here.

 

PFAS and flame retardants: prohibition and restrictions in consumer goods

 

Since the beginning of 2021, different US states have published proposals and bills related to chemical substances which can be found in different consumer goods.

 

The table below summarises the more relevant legislations and proposals:

 

State

Substance

Scope

Requirements

Proposed Effective Date

Bill

Connecticut

PFAS

Consumer products

Prohibited

-

Proposed SB 404

Delaware

Flame retardants

Residential upholstered furniture

≤ 0.1% each of TBB, antimony, TBPH, SCCP, Deca-BDE, HBCD, TBBPA, TDCPP, TCEP and TCPP and
≤ 0.1% of a mixture containing 1 or more of the above FRs

01/07/2021

HB 77

Delaware

Flame retardants

Products for children under 12 that are primarily intended for use in homes

≤ 0.1% each of TBB, antimony, TBPH, SCCP, Deca-BDE, HBCD, TBBPA, TDCPP, TCEP and TCPP and
≤ 0.1% of a mixture containing 1 or more of the above FRs

01/07/2021

HB 77

Iowa

Flame retardants

Residential upholstered furniture

≤ 0.1% each FR and ≤ 0.1% of a FR mixture (fabrics, coverings or cushioning materials)

01/01/2022

HF 293

PFAs

Fire firefighting personal protective equipment

Prohibited

New York 

Flame retardants

Residential upholstered furniture

Prohibits halogenated FRs and phosphorus-bromine FRs

01/07/2021

A3031

New York

Flame retardants

Residential upholstered furniture

Prohibits halogenated FRs and phosphorus-bromine FRs

01/07/2021

S2178

 

Flame Retardants Bill in Massachusetts

 

On 1 January 2021, the Governor of state of Massachusetts signed Bill H.4900 , which aims to protect children, families, and firefighters from harmful flame retardants by regulating flame retardants into different categories such as bedding, carpets, children’s products, residential upholstered furniture or window treatment.

 

Effective since 31 December 2021, these products shall not contain the following chemicals substances or an analogue in an amount greater than or equal to 1000 ppm:

 

  • Tris(1,3-dichloro-2-propyl)phosphate (TDCPP) (CAS number: 13674–87–8);
  • Tris(2-chloroethyl)phosphate (TCEP) (CAS number: 115–96–8);
  • Antimony trioxide (CAS number 1309–64–4);
  • Hexabromocyclododecane (HBCD) (CAS number 25637–99–4);
  • Bis(2-Ethylhexyl)-3,4,5,6- tetrabromophthalate (TBPH) (CAS number 26040–51–7);
  • 2-EthylhexYl-2,3,4,5-tetrabromobenzoate (TBB) (CAS number 183658– 27–7);
  • Chlorinated paraffins (CAS number 85535–84–8);
  • Tris (1-chloro-2-propyl) phosphate (TCPP) (CAS number 13674–84–5);
  • PentaBDE (CAS number 32534-81-9);
  • OctaBDE (CAS number 32536-52-0);
  • Tetrabromobisphenol A (TBBPA) (CAS number 79-94-7)

 

Legislation (S.6829/A.8829-A) banning most harmful uses of Trichloroethylene (TCE)

 

On 23 December 2020, the Governor of New York signed legislation (S.6829/A.8829-A), banning the most harmful uses of trichloroethylene including, but not limited to, as an intermediate chemical in the production of other chemicals, vapor degreaser, refrigerant or in any other manufacturing or industrial cleaning process or use beginning 1 December 2021.

 

TCE is typically used as an industrial cleaning and degreasing agent in manufacturing processes.

 

TCE is a known carcinogen, causes development disorders, and is harmful to the environment.

 

California Proposition 65 settlement agreements

 

Companies operating businesses in California are required to state the presence of hazardous chemical substances in their products in accordance with California Proposition 65 warnings, as a measure to protect the drinking water and public in the state.

 

Failure to comply with the regulation could lead to court cases. Several key recent Prop 65 settlement agreements concerned the following substances:

 

Chemical substance

Source of substance

Examples where it could be found

Di(2-ethylhexyl)phthalate (DEHP)

Flexible plastic parts of a product.

Shower curtains, furniture and automobile upholstery, garden hoses, floor tiles, and coverings on wires and cables, rainwear and shoes, lunchboxes, binders, and backpacks.

In plastic food packaging materials.

In medical devices and equipment, including some types of blood and intravenous solution bags, tubing for dialysis, feeding tubes, oxygen masks, and surgical gloves.

Lead and Lead Compounds

It is a metal that is found in nature and used in many industries and products.

Ceramic dishes and pottery and pewter and crystal glassware.

Baby bibs, purses, garden hoses, and other products made of vinyl or imitation leather.

Toys, white oil paints, costume jewellery, traditional cosmetics (such as kohl, kajal, al-kahal, or surma), and hair dyes.

Brass faucets and fittings.

Lead-acid batteries used in motorized equipment and vehicles such as cars, trucks, motorcycles, and boats.

Lead fishing sinkers and curtain weights.

Diisononyl Phthalate (DINP)

Flexible plastic parts of a product.

Polyvinyl chloride (PVC, vinyl) flooring, materials used in automobile interiors, wire and cable insulation, gloves, tubing, garden hoses, and shoes.

Inks and pigments, adhesives, sealants, paints and lacquers.

Butyl Benzyl Phthalate (BBP)

Flexible plastic parts of a product.

Vinyl flooring, sealants, and paints.

Handbags, belts, footwear and other artificial leather items that are made with polyvinyl chloride (commonly referred to as vinyl).

Di-n-hexyl Phthalate (DnHP)

Flexible plastic parts of a product.

Vinyl products although its use has decreased.

Di-n-butyl Phthalate (DBP)

Flexible plastic parts of a product.

Wire and cable insulation, gloves, tubing, garden hoses, shoes, and personal care products, including some perfumes and other products containing fragrances, and nail polishes.

Di-isodecyl Phthalate (DIDP)

Flexible plastic parts of a product.

Polyvinyl chloride (PVC, vinyl) tubing, materials used in automobile interiors, garden hoses, raincoats, binders, storage cases, tile flooring, shower curtains, and bath mats.

Diisononyl Phthalate (DINP)

Flexible plastic parts of a product.

Polyvinyl chloride (PVC, vinyl) flooring, materials used in automobile interiors, wire and cable insulation, gloves, tubing, garden hoses, and shoes. Non-PVC products, such as some inks and pigments, adhesives, sealants, paints and lacquers. non-PVC products, such as some inks and pigments, adhesives, sealants, paints and lacquers.

 

Amendment proposal of the California Code of Regulations

 

On 8 January 2021, the Office of Environmental Health Hazard Assessment (OEHHA) published a notice of Proposed Rulemaking related to certain sections of Article 6 of Title 27 of the California Code of Regulations, clear and reasonable warnings Short-form Warnings.

 

The amendments include:

 

  • Section 25601, Safe Harbor Clear and Reasonable Warnings – Method and Content,
  • Section 25602, Consumer Product Exposure Warnings – Methods of Transmission,
  • Section 25603, Consumer Product Exposure Warnings – Content, and
  • Section 25607.1 Food Exposure Warnings – Methods of Transmission.

The aim is to facilitate businesses’ compliance with the Act by providing clarification on guidance concerning the provision of safe harbor warnings under Proposition 65. The agency will provide clarification regarding the use of short-form warnings, which should only be used for small products with limited label space where a full-length warning will not fit. The use of short-form warnings for exposures to listed chemicals from food will be also clarified.

 

The public comment period is being extended to March 29, 2021.

 

Standards updates

 

See below a table summarising the most recent ASTM standards updates:

 

Reference

Title

ASTM F2326 – 04(2021)

Standard Test Method for Collection and Analysis of Visible Emissions from Candles as They Burn

 

International

 

Regulatory proposals notified to WTO

 

Please see the below table summarising the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

 

Notification number / Link

Country

Title

G/TBT/N/CHL/550

Chile

Approval of the Ministry of the Environment preliminary draft National Strategy on Marine Litter and Microplastics

G/TBT/N/JPN/685

Japan

Revision of the "Order for Enforcement of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc."

G/TBT/N/IND/199

India

Ortho Phosphoric Acid (Quality Control) Order, 2021

G/TBT/N/THA/590

Thailand

Draft Ministerial Regulation on Synthetic Dyestuffs: Direct Dye (TIS 739-25XX(20XX))

G/TBT/N/THA/591

Thailand

Draft Ministerial Regulation on Synthetic Dyestuffs: Reactive Dye (TIS 740-25XX(20XX))

G/TBT/N/THA/592

Thailand

Draft Ministerial Regulation on Synthetic Dyestuffs: Vat Dye (TIS 760-25XX(20XX))

G/TBT/N/THA/593

Thailand

Draft Ministerial Regulation on Synthetic Dyestuffs: Sulphur Dye (TIS 2344-25XX(20XX))

G/TBT/N/THA/594

Thailand

Draft Ministerial Regulation on Synthetic Dyestuffs: Acid Dye (TIS 2532-25XX(20XX))

G/TBT/N/UKR/179

Ukraine

Draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Technical Regulation on Safety of Chemical Products"

G/TBT/N/UKR/180

Ukraine

Draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Technical Regulation on Hazard Classification, Precautionary Labeling and Packaging of Chemical Products"

G/TBT/N/UKR/182

Ukraine

Draft Resolution of the Cabinet of Ministers of Ukraine "On Amendments to the Technical Regulation for Detergents"

G/TBT/N/USA/1697

United States

Hazard Communication Standard

G/TBT/N/EU/778

Europe

Directive (EU) 2018/851 of the European Parliament and of the Council of 30 May 2018 amending Directive 2008/98/EC on waste

G/TBT/N/USA/1685

United States

Asbestos (Part 1: Chrysotile Asbestos); Final Toxic Substances Control Act (TSCA) Risk Evaluation; Notice of Availability

G/TBT/N/USA/1687

United States

n-Methylpyrrolidone (NMP); Final toxic Substances Control Act (TSCA) Risk Evaluation; Notice of Availability

G/TBT/N/IND/186

India

Ethylene Vinyl Acetate Copolymers (Quality Control) Order, 2020

G/TBT/N/IND/187

India

Linear Alkyl Benzene (Quality Control) Order, 2020

G/TBT/N/IND/194

India

Synthetic Micro-Fibres for use in Cement-Based Matrix (Quality Control) Order, 2020

 

Canada

 

Cyclical Enforcement Project 2019-2020: Consumer chemicals and container Regulations, 2001

 

On 20 January 2021, the Canadian government published results related to the Cyclical Enforcement Project 2019-2020.

 

The aim of this Cyclical Enforcement (CE) project was to verify industry´s compliance  with the requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001), regarding consumer chemicals. Flammability, corrosivity, viscosity and pH testing, as well as a visual evaluation of 60 different product labels were carried out. The compliance verification inspections resulted in 12 recalls, 1 stop sale, 23 stop distributions, 2 corrections and 10 commitments to address non-compliance.

 

Below is the report relating to consumer chemicals and Containers Regulations:

 

Asia

 

Israel´s new draft law to reduce harmful effects of chemicals on humans and the environment

 

Israel´s Ministry of Environmental Protection has promoted establishing a mechanism for registering industrial chemicals and published a memorandum of a law titled “Industrial Chemicals Registering Law, 5781-2020”. The new draft law establishes a new mechanism aiming to reduce harmful effects to humans and the environment from chemicals used as raw materials.

 

Manufacturers and importers of over 10 tons of industrial chemical substances per year will be required to report to the new online Chemicals Registry at the Ministry of Environmental Protection. The information required is primary data and a full Safety Data Sheet (SDS).

 

The following shall be exempted from registration as defined in the Law´s Second Annex:

 

  • Part 1: The chemical is regulated by different legislation
  • Part 2: A chemical substance with a known risk level
  • Part 3: A chemical substance from a natural source
  • Part 4: Polymers, except for free monomers in a weight concentration of 2 or more present from the mixture.

The law is due to enter into force on 1 March 2023, and the establishment of the Chemical Inventory Registry should be completed and launched by 1 September 2024. Final date for comments is 07th March.

 

For more information, please visit the website.

 

Eurasia

 

Updated chemical substances inventory according to Eurasia REACH

 

The Eurasian Economic Union (EAEU) consisting of Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan, passed a new chemicals law in 2016. The “Technical Regulation on Safety of Chemical Products of 7 October 2016 (Decree No 1019)”, otherwise known as Eurasia REACH, which will be fully in place at the end of 2021 or early 2022.

 

According to Eurasia REACH, companies are required to submit registrations to a member state competent authority for all chemical substances they place or plan to manufacture or import into the EAEU market. The type of registration varies depending on the status of the chemical: new or existing, comparable with the pre-REACH chemicals legislation in the EU.

 

Manufacturers or importers will have to register new substances if they exceed the threshold of 0.1% in a formulation, irrespective of the tonnage bands.

 

According to Eurasia REACH, existing substances is required to be notified to the chemicals inventory. Russian authorities published an update of the chemicals substances inventory, including all the submitted notifications received until 1 August 2020.

 

The inventory can be found here.

 

On the 17 February 2021, the Eurasian Economic Commission (EEC) has published new draft version of the 2nd tier implementing regulations under Technical Regulation on Safety of Chemical Products TR041. The draft document is available on the EAEU legal portal and any interested person can submit their comments until 1st April 2021.

 

The 2nd tier legislation has to be approved before Eurasia REACH can enter into force. Until then, the date of entry into force of Eurasia REACH remains unclear.

 

Product Recalls / Alerts

 

Below you will find a monthly 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 1 to week 7 of 2021:

 

Chemical risks

Number of alerts

Notes

1

Construction products: sealing slurry

The product contains chromium VI (measured value: 0.0053% w/w). The product does not comply with the REACH Regulation.

1

Chemical products: Suspension oil

Ingestion or aspiration of the mineral oil blend, due do its low viscosity combined with the high content of classified hydrocarbon in the mixture, maybe be fatal if swallowed and enters airways.
The product does not comply with the Classification, Labelling and Packaging (CLP) Regulation.

1

Chemical products: Hand disinfectant

The product contains methanol (measured value: 7 % by weight), which is acutely toxic to the central nervous system and to the eyes. Furthermore, the required hazard pictograms are missing. product does not comply with the Biocidal Products and the Classification, Labelling and Packaging (CLP) Regulations.

1

Chemical products: Hand disinfectant

The product contains an insufficient amount of ethanol (measured values: 11% by volume). Consequently, it does not kill bacteria or viruses, which could then reach the user, increasing the risk of infection. Moreover, the product contains methanol (measured value: 26% by weight), which is acutely toxic to the central nervous system and to the eyes. Furthermore, the required hazard pictograms and warnings are missing.
The product does not comply with the Biocidal Products Regulation and the Classification, Labelling and Packaging (CLP) Regulations.

1

Chemical product: Hand disinfectant

The product contains Polyhexanide (PHMB) (declared concentration: 0.8%). The product does not comply with the Biocidal Products Regulation.

1

Protective equipment: Inflatable armbands

The product contains bis (2-ethylhexyl) phthalate (DEHP) (measured value: 17,59 % by weight).
The product does not comply with the REACH Regulation.

5

Jewelry: The product contains an excessive amount of lead (measured value: 45 % by weight). The product does not comply with the REACH Regulation.

11

Jewelry: The pendant contains an excessive amount of cadmium (measured values up to: 68% by weight).
The product does not comply with the REACH Regulation.

3


Jewelry: The product releases an excessive amount of nickel (measured value up to 6.69 per week). The product does not comply with the REACH Regulation.

1

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.

3

Toy slime: It contains an excessive amount of 5-Chloro-2-methyl-isothiazolin-3(2H)-one (CMI) and 2-methylisothiazolin-3(2H)-one (MI). Does not comply with the requirements of the Toy Safety Directive.

10

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

1

Ballons: The amount of N-nitrosatable substances released by the balloons is too high. Does not comply with EN 71-12.

2

Toy jewelry set: The plastic material contains an excessive amount of Di-isononylphthalate (DINP) and Di(2-ethylhexyl)phtalate (DEHP). The product does not comply with the REACH Regulation.

6

Leather clothes: It contains chromium (VI). Does not comply with the REACH Regulation.

 

U.S.

 

From the 1st January 2021 to the 20th February of 2021, CPSC (Consumer Product Safety Commission) published the following recalls regarding chemical risks:

 

Chemical risks

Number of alerts

Notes

1

Jewelry: The product has elevated levels of nickel, posing a risk of skin irritation.

 

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Cosmetics & Personal Care


 

 

Brexit & Cosmetic Products: What’s Changing?

 

Since the end of the transition period on 31st December 2020, the UK Statutory Instruments - The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 became applicable in Great Britain (GB). Schedule 34 of this text, named the UKCR : United Kingdom Cosmetics Regulations, concerns cosmetic products, and generally mirrors the European Commission Cosmetics Regulation n°1223/2009. These new regulations do not apply to Northern Ireland.

Read more >>

 

Eurofins Cosmetics & Personal Care at PCHI 2021

 

The upcoming PCHi conference will take place on 24th to 26th March 2021 in Shenzhen! Meet Eurofins Cosmetics & Personal Care at booth 1B74 to discover more about:

  • Safe, the new clean
  • Hygiene, the new chic
  • Proactive, the new beauty

Read more >>

 

Bayer and Eurofins disclose their discoveries on dry skin

 

Eurofins Evic Romania, part of Eurofins Cosmetics & Personal business line, has established a research partnership with Bayer, to assess the performance in healthy adults with dry skin of three new dexpanthenol-containing emollients containing increasing lipid.

Read more >>

 

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Furniture


 

 

US

 

New Californian requirements for upholstered furniture

 

In December 2020, the H.R. 133 on the Consolidated Appropriations Act, 2021 was published. This amendment includes the ‘Title XXI – COVID-19 Regulatory Relief and Work from Home Safety Act’.

 

The main points are:

 

  • Upholstered Furniture must meet to the California Technical Bulletin 117– 2013 ‘Requirements, Test Procedure and Apparatus for Testing the Smolder Resistance of Materials Used in Upholstered Furniture’ as the federal flammability standard.
  • It does not include: outdoor furniture, mattresses, foundations, any bedding products, or furniture that is used exclusively for the purpose of physical fitness and exercise.
  • A permanent label located on the product with the statement ‘Complies with US CPSC requirements for upholstered furniture flammability’.

Upholstered furniture in California must comply with both federal and Californian requirements.

 

It will become effective from 25th Jun 2021.

 

New safety and performance standard for Occasional-Use Seating

 

On 11th January 2021, The American National Standards Institute (ANSI) has approved the new safety and performance standard ANSI/BIFMA X6.4-2021 for Occasional-Use Seating.

 

This standard covers:

 

  • Specific tests
  • Laboratory equipment
  • Conditions of test
  • Recommended minimum levels to be used in the testing and evaluation of the safety, durability, and structural adequacy of Occasional-Use Seating products.

To read the BIFMA notice, click here.

 

Product Recalls / Alerts

 

Below you will find a monthly summary 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 one alert regarding furniture has been reported, from week 4 until week 7 of 2021.

 

Type of Risk

Number of alerts

Notes

 Injuries

1

Chair is not sufficiently stable and the rolling resistance is too low. It does not comply with EN 1335-2.

 

U.S.

 

Between 21st January and 20th  February 2021, the CPSC (Consumer Product Safety Commission) published the following recalls4 recalls furniture.

 

Type of Risk

Number of alerts

Notes

Death or injuries to children

1

Chests and dressers are unstable.

Injury

1

Shelves can fail to support the 800-pound weight load as stated on the packaging.

Fall 

1

Chair’s back can detach

 Electric shock 

1

The convenience charging receptacles and/or USB ports installed in the accent tables can have an electrical issue resulting in reverse polarity

 

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Softlines and Leather


 

 

Europe

 

Nonylphenol and its ethoxylates restriction

 

On 3 February 2021, the Nonylphenol and its ethoxylates (NPEs) restriction came into effect for textile articles. NPEs concentrations equal to or greater than 0.01 % by weight are not allowed in any textile articles or their constituent parts. This does not apply to second-hand textile articles or new textile articles produced, without the use of NPE, exclusively from recycled textiles.

Read more >>

 

New update of Candidate list of Substances of Very High Concern (SVHCs)

 

On 19 January 2021, the ECHA (European Chemicals Agency) released the new Candidate list of SVHCs. With the addition of two new substances, the latest list of SVHCs now contains 211 substances.

Read more >>

 

Updates to EU Standards for Safety of Children's Clothing: CEN/TS 17394-1:2021, CEN/TS 17394-3:2021 and CEN/TS 17394-4:2021

 

Published in January 2021, CEN/TS 17394-1:2021, CEN/TS 17394-3:2021 and CEN/TS 17394-4:2021, together with EN 17394-2: 2020, on test methods and specification by CEN (European Committee for Standardization) will replace the test methods and requirements of the CEN/TR 16792. 

Read more >>

 

ECHA updates the list of testing methods for azocolourants (REACH Annex XVII)

 

On 16 December 2020, the European Union (EU) has published the following amendment.

Read more >>

 

CEN standards updates

 

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

Read more >>

 

Regulatory proposals notified to WTO

 

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

Read more >>

 

US

 

Persistent, Bioaccumulative, and Toxic Chemicals list

 

On 6 January 2021, The Daily Journal of the United States Government published the rules on Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h) of the Toxic Substances Control Act (TSCA).  The US Environmental Protection Agency (EPA) prohibits the following substances in articles and chemicals with the aim to reduce the exposition to human and environment. It was effective from 5 February 2021.

Read more >>

 

PFAS and flame retardants: prohibition and restrictions in consumer goods

 

Since the beginning of 2021, different U.S. states have published proposals and bills related to chemicals substances which can be found in different consumer goods.

Read more >>

 

New Californian requirements for upholstered furniture

 

In December 2020, the H.R. 133 on the Consolidated Appropriations Act, 2021 was published. This amendment includes the ‘Title XXI – COVID-19 Regulatory Relief and Work from Home Safety Act’which will become effective from 25 Jun 2021.

Read more >>

 

Flame Retardants Bill in Massachusetts

 

On 1 January 2021, the Governor of State of Massachusetts signed the Bill H.4900 An Act to protect children, families, and firefighters from harmful flame retardants by regulating flame retardants in different product categories, such as bedding, carpeting and children’s products.

Read more >>

 

California Proposition 65 settlement agreements

 

Companies operating their businesses in California are required to state the presence of hazardous chemical substances in their products in accordance to California Proposition 65 warnings, as a measure to protect the drinking water and public in the state.

Read more >>

 

ASTM Standards updates

 

Please see the following table summarising the most recent ASTM standards updates.

Read more >>

 

India

 

Footwear Quality Control Orders

 

In July 2021, the following three orders regarding Quality Control Orders related footwear products will come into effect in India.

Read more >>

 

Regulatory proposals notified to WTO

 

Please see the following table summarising the most recent Indian 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 >>

 

U.S.

 

Between 1 January and 20th February 2021, the CPSC (Consumer Product Safety Commission) published the following recalls.

Read more >>

 

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Toys & Childcare


 

 

Europe

 

EN 71-4:2020 Safety of Toys on Experimental Sets for Chemistry and Related Activities Published

 

In December 2020, a new version of the EN 71-4:2020 Safety of Toys – Part 4: Experimental Sets for Chemistry and Related Activities was published by the European Committee for Standardisation (CEN).

Read more >>

 

New update of Candidate list of Substances of Very High Concern (SVHCs)

 

On 19 January 2021, the ECHA (European Chemicals Agency) has released the new Candidate list of SVHCs. With the addition of two new substances, the current list of SVHCs contains 211 substances.

Read more >>

 

Standards updates

 

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

Read more >>

 

Benelux

 

The end of the bamboo period is near

 

On 15 February 2021, Belgium, the Netherlands and Luxembourg (Benelux) published a joint letter on the use of bamboo or other unauthorised additives in plastic materials that come into contact with food and are placed on the EU market.

Read more >>

 

France

 

Ban on disposal of unsold children care products

 

On 28 December 2020, the French authorities published Decree n ° 2020-1724 prohibiting the disposal of unsold non-food items and various provisions to fight against waste.

Read more >>

 

Ban of plastic toys in children’s menus

 

Starting from 2022, restaurants in France will not be allowed to provide free plastic toys together with their children’s menus.

Read more >>

 

UK

 

UK Manufacturing guidelines

 

UK authorities have updated the following guidance in relation to the UKCA and UKNI marking (non-exhaustive list).

Read more >>

 

Consolidated list of toy standards

 

On 9 December 2020, the UK Department for Business, Energy and Industrial Strategy published a notice related to toys, which provides a consolidated list of designated standards for toy safety. It is in support of the toys (Safety) Regulations 2011 (as amended).

Read more >>

 

U.S.

 

Standards updates

 

See the following table summarising the most recent ASTM standards updates.

Read more >>

 

CPSC publications

 

On 19 January 2021, the Consumer Product Safety Commission (CPSC) published Revisions to Safety Standard for Infant Swings. Furthermore, on 8 January 2021, the Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend certain sections of Article 6 of Title 27 of the California Code of Regulations.

Read more >>

 

Flame Retardants Bill in Massachusetts

 

On 1 January 2021, the Governor of state of Massachusetts signed the Bill H.4900, which aims to protect children, families, and firefighters from harmful flame retardants by regulating flame retardants into different categories such as bedding, carpets and children’s products.

Read more >>

 

Amendment proposal of the California Code of Regulations

 

On 8 January 2021, the Office of Environmental Health Hazard Assessment (OEHHA) published a notice of Proposed Rulemaking related to certain sections of Article 6 of Title 27 of the California Code of Regulations.

Read more >>

 

Upholstered furniture flammability federal standard

 

On 21 December 2020, Consolidated Appropriations Act, 2021 (Bill H.R. 133) was passed and then signed into law by the US president a few days later.

Read more >>

 

Australia

 

On 18 December 2020, the Australian Authorities published the following legislations relating to button/coin batteries and consumer products that contain these types of batteries

Read more >>

 

Canada

 

Cyclical Enforcement Reports 2019-2020

 

On 20 January 2021, the Canadian government published results related to the Cyclical Enforcement Project 2019-2020.

Read more >>

 

Flammability requirements for children’s costumes

 

On 21 December 2020, Health Canada published a notice relating to flammability requirements for children’s costumes to remind manufacturers, agents and retailers on the Heath Canada’s policy regarding children’s costumes, particularly how the policy relates to the flammability requirements set out in regulations under the Canada Consumer Product Safety Act (CCPSA).

Read more >>

 

International

 

Regulatory proposals notified to WTO

 

Please see the below table summarising 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 >>

 

U.S.

 

From the 01 January 2021 to the 20th February of 2021, CPSC (Consumer Product Safety Commission) published the following recalls regarding Childcare and children’s products

 

Type of Risk

Number of alerts

Notes

choking

1

Toy Confetti Trumpets: small plastic pieces inside the toy trumpets can come loose and can be ingested by children.

 

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


 

 

Eurofins labs at work worldwide to keep you healthy and safe

 

We are proud to inform our subscribers that our laboratories across the U.S.A., Europe and Asia are at work, providing a global service offer for testing, inspection and regulatory services focused on medical face masks, gloves and gowns, respiratory protective devices and equipment, its materials and components, as well as disinfectants and hand sanitizers, to serve the increasing demand caused by the severe coronavirus pandemic.

 

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.

 

France

 

New requirements for non-sanitary masks

 

On 27 January 2021, the French authorities published  Decree No. 2021-76 and on 28th January 2021, the informative note of 29th March 2020 was updated.

 

This Decree prescribes the general measures necessary to face the COVID-19 epidemic and defines the use of masks.

 

The informative note indicates the usage requirements, marketing conditions, technical specifications and markings for general public masks reserved for non-sanitary use.

 

The main points are:

 

  • A non-sanitary mask is a fabric mask with a "general public filtration greater than 90%". It is usually washable and reusable, designed to avoid the projection of drops and filter emitted particles of a size equal to or greater than 3 microns.
  • If the claim ‘The filtration performance equal to or greater than 90%’ is used, those responsible of products must:
    • Ensure that the masks are tested by a laboratory validated by DGE (DGA method)
    • Use a new logo (see Annex V of the informative note) or indicate visibly, legibly and in an easily accessible way the filtration performance of the mask on the packaging.
    • Publish the results on the DGE website (Registered until March 31, 2021).

Masks that do not comply to these technical requirements can be marketed but must not use the official logo or use a non-sanitary mask statement.

 

Spain

 

New Order for Hygienic mask

 

On 13 February, the Spanish Ministry of Consumer Affairs (CCAA) published order CSM / 115/2021, which establishes the information and marketing requirements for hygienic masks. This order will replace the Order SND / 354/2020 on 19th April 2021.

The main points of this CSM / 115/2021 order are:

  • The term ‘hygienic mask’ excludes any other type of mouth guard as defined in the laws applicable to Medical Devices or Personal Protective Equipment.
  • The masks must be tested by an accredited laboratory (UNE-EN ISO / IEC 17025).
  • All hygienic masks must indicate:
    • The standards they meet
    • Technical specifications
    • The data on the filtration efficiency of the material, the resistance to respiration or permeability to air and the laboratory used to carry it out
    • Reusable masks must include data from before and after the washing cycles indicated by the manufacturer
    • The place of origin must also appear
    • The labelling may not include references to other types of products that give rise to deception about the nature of the product.
  • For filters that are sold independently of the mask:
    • They must cover the largest possible surface area of ​​the mask and ensure that there are no areas where inhaled / exhaled air can pass unfiltered.
    • It must be specified with which fabric the data from the bacterial filtration and breathability tests were obtained, since the mask-filter assembly must meet the requirements of the standard.
  • The marketing of masks outside of the original container, or any other type of format that does not guarantee compliance with this order, is prohibited.
  • Those responsible for the product have 30 days, from the date of publication, to adapt to this new order.

Failure to comply with the rules related to labelling, packaging and advertising of goods and services is an offense and the CCAA may put penalty on the sellers and request product recall.

 

Guidance for the manufacture and selection of masks

 

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

 

Hygienic masks: Generalities and frequently asked questions

 

Surgical Masks

 

 

Regulatory proposals notified to WTO

 

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

 

Notification number

Countries

Title

G/TBT/N/ESP/44

Spain

Draft Ministerial Order establishing information and marketing requirements for hygiene masks.

 

Product Recalls / Alerts

 

Europe

 

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

 

The following alerts regarding Personal Protective equipment have been reported, from week 1 to week 7 of 2021.

 

Type of Risk

Number of alerts

Notes

Health risk / other

6

Particle filter mask

The product bears a CE marking but is not certified as protective equipment by the relevant body. It does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.

5

Particle filter mask

The product advertises a protective potential against (viral) particles but its filtering capacity has not been certified by a relevant (European) body. It does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.

2

Particle filter mask

It is accompanied by a declaration of conformity to Regulation (EU) 2016/425 and to the European standard EN 149:2009, but it has not been certified as such by the relevant European body. It does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.

 

UK

 

New specifications for community face covering

 

The British Standards Institution (BSI) has issued the first version of BSI Flex 5555 Community face coverings — Specification for free in its website.

 

The main points of Specification are to provide:

 

  • Minimum performance requirements to filtration and transmission, and use of materials;
  • General information on single and multi-use face coverings, plus cleaning requirements for multi-use coverings;
  • A test method for testing houses;
  • Washing conditions, markings and instructions for use.

A second version of the Specification is expected to be published in February 2021 after the end of consulting period.

 

US

 

Standard for barrier face covering

 

ASTM International (ASTM) has approved the standard F3502 Safety Specifications for consumer face coverings.

 

A consumer face covering is not a medical mask (FDA) or personal protective equipment (NIOSH); instead, its main use is to create a barrier to reduce the number of expelled droplets from the wearer’s nose and mouth. It also offers protection by filtering particles and reducing the amount inhaled by the user.

 

Main requirements

Performance

Particles filtration efficiency (PFE)

Breathing resistance

 

Level 1 ≥ 20%;

Level 2 ≥ 50%;

Level 1 Inhalation ≤ 15 mm H2O;

Level 2 Inhalation ≤ 5 mm H2O

Flammability

 

Tested per 16 CFR 1610 (Class 1 or Class 2)

Construction

 

  • Covering at least wearer’s face and mouth.
  • Correct fit to minimise leakage.
  • Retention system (nose and mouth) during period of use.
  • No sharp edges, sharp points or burrs.
  • Sizing
  • The use of vents, valves, or other features during exhalation is not allowed.
  • Quantitative leakage assessment (design analysis or ASTM F3407).

Conformity Assessment

 

  • Model A according to ASTM F23050
  • The performance test (PFE and Breathing resistance) must be done by accredited laboratory (ISO 17025)

Labelling

 

  • Manufacturer’s name and information
  • Technical information (PFE and breathing resistance (Level 1 and Level 2 or continuous performance pictogram))
  • Material
  • Traceability information

 

International

 

Regulatory proposals notified to WTO

 

See below a table summarising some recent notifications to the World Trade Organization (non-exhaustive):

 

Notification number / Link

Country

Title

G/TBT/N/BRA/1112

Brazil

Resolution number 444, 10 December 2020
It establishes temporary and extraordinary requirements for the fabrication, importation and commercialization of personal protective equipment identified as priority for use by health services, due to the COVID-19 pandemic.

 

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