JavaScript is disabled. Please enable to continue!
Media Centre >> News >> Eurofins | August 2019 regulatory Newsflash compilation | Chemicals

Eurofins | August 2019 regulatory Newsflash compilation | Chemicals

Sidebar Image

Thursday, July 25, 2019

Eurofins newsflash Chemical

 

Europe

 

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

 

On 16th July 2019, the ECHA (European Chemicals Agency) has released the new Candidate List of SVHCs.

 

Read more >>

 

Recast of Regulation on Persistent Organic Pollutants

 

On 25th June 2019, a Recast of the Regulation on persistent organic pollutants (POPs) was published in the Official Journal of the European Union.

 

Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (Recast)”

 

This new Regulation entered into force on July 15th 2019 and repeals the previous POP Regulation (EC) No 850/2004 and all its amendments.

 

The aim of this Recast is to give more clarity (the previous POP Regulation was modified 12 times) while ensuring an efficient implementation of legislation on chemicals and alignment with other relevant laws of the European Union, such as REACH and the latest amendments to the Stockholm Convention, which provides the global legal framework for the elimination of production, import and export of persistent organic pollutants.

 

Same as for REACH, CLP, BPR and PIC Regulations, now the European Chemicals Agency (ECHA) will also be responsible for the administrative, technical and scientific aspects of POP Recast Regulation.

 

This new regulation has toughened the requirements applicable to persistent organic pollutants and includes important changes to terminology to encourage consistency with REACH Regulation. Hence, the definitions for substances, mixtures (former “preparation”) and articles have been aligned with REACH.

 

In addition, “Unintentional Trace Contaminant”, also known as UTC, is now defined as the “level of a substance that is incidentally present in a minimal amount, below which the substance cannot be meaningfully used, and above the detection limit of existing detection methods”.

 

Some relevant updates of POP Recast Regulation are summarized in Table 1 below (non-exhaustive list):

 

Table 1. Main updates of POP Recast Regulation.

 

Substance

Regulation (EU) 2019/1021 
(POP Recast)

Regulation (EU) 850/2004 (POP)

ANNEX I – PART A: Substances listed in the Convention and in the Protocol as well as substances listed only in the Convention. Specific exemption on intermediate use or other specification.

As an unintentional trace contaminants (UTC):

  • Tetrabromodiphenyl ether (CAS 40088-47-9 and others; EC 254-787-2 and others)
  • Pentabromodiphenyl ether (CAS 32534-81-9 and others; EC 251-084-2 and others)
  • Hexabromodiphenyl ether (CAS 36483-60-0 and others; EC 253-058-6 and others)
  • Heptabromodiphenyl ether (CAS 68928-80-3 and others; EC 273-031-2 and others)
  • Decabromodiphenyl ether; decaBDE (CAS 1163-19-5; EC 214-604-9)

≤ 10 mg/kg each in substances

≤ 500 mg/kg (sum in mixtures or articles) 
(subject to review by 16 July 2021 by the European Commission)

 

*With some exemptions including electrical and electronic equipment within the scope of Directive 2011/65/EC (RoHs)

 

Deca-BDE: Newly added to POP Recast in Annex I

Note: Deca-BDE was restricted, up to now, under REACH Annex XVII Entry 67 with a limit of 1000 mg/kg

≤ 10 mg/kg each of tetra-, penta-, hexa- and hepta-BDE in substances, preparations, articles or parts thereof

(Deca-BDE: Not listed)

  • Pentachlorophenol and its salts and esters (PCP) (CAS 87-86-5 and others; EC 201-778-6 and others)

No specific exemption on intermediate use or other specification – Not Permitted

 

Newly added to POP Recast in Annex I

Note: PCP was restricted, up to now, under REACH Annex XVII Entry 22 in Substances and Mixtures with a limit of 1000 mg/kg

Not listed

  • Hexachlorobutadiene (CAS 87-68-3; EC 201-765-5)

Substances transferred from Part B of Annex I of POP Regulation (EC) No 850/2004 to Part A of Annex I of POP Recast Regulation (EU) 2019/1021

Not listed

  • Polychlorinated naphthalenes (PCNs) (CAS 70776-03-3 and others; EC 274-864-4 and others)
  • Short chain chlorinated paraffins (SCCPs) (CAS 85535-84-8 and others; EC 287-476-5)

ANNEX III – List of substances subject to release reduction provisions

  • Hexachlorobutadiene (CAS No 87-68-3; EC 201-765-5)
  • Polychlorinated naphthalenes (PCNs) (CAS No 70776-03-3 and others; EC 274-864-4 and others)

Two new added POPs in Annex III of POP Recast Regulation (EU) 2019/1021 enlarging the number of POPs in Annex III from five to seven

Not listed

ANNEX IV– List of substances subject to waste management provisions set out in Article 7

  • Decabromodiphenyl ether; decaBDE (CAS 1163-19-5; EC 214-604-9)

New added under Annex IV of POP Recast Regulation (EU) 2019/1021

Not listed

 

For more information click here.

 

It has to be noted that, according to a guidance document issued by the European Commission regarding the relationship between REACH and the Stockholm Convention and POP Regulation:

 

“... Annex XVII to REACH already contains a restriction in relation to a substance which is subsequently listed under the POP Convention:

 

In these circumstances, the practice is to implement the listing in the POP Convention by means of amending the appropriate Annex(es) to the POP Regulation and to remove the restriction from Annex XVII to REACH (examples of this are PFOS, SCCPs and Penta-DBE).

 

Article 131 of REACH provides the enabling power for the Commission Regulation amending Annex XVII.

 

The entry in the appropriate Annex to the POP Regulation should cover at least the bans under the Stockholm Convention and existing restrictions in Annex XVII to the REACH Regulation.”

 

Based on the above, it is, therefore, expected that decaBDE and PCP (newly added to POP Regulation Recast) would be removed from Annex XVII to REACH Regulation.

 

Recent publications by European Commission

 

Below you will find some documents recently published in the Official Journal of the European Union.

 

Date

Reference

Title

27-06-2019

2019/1058

Decision of the EEA Joint Committee No 170/2017 of 22 September 2017 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

27-06-2019

2019/1059

Decision of the EEA Joint Committee No 171/2017 of 22 September 2017 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

 

Draft texts notified to the European Commission

 

The following draft document has been recently notified to the European Commission:

 

Reference

Date

Country

Title

2019/330/FIN

08-07-2019

Finland

Draft Government bill to Parliament for an act amending the Chemicals Act

 

Additional Recent Updates Regarding REACH

 

Below table includes a summary of the main recent updates (non-exhaustive) regarding REACH Regulation (EC) No 1907/2006:

 

Summary of main recent updates

Date

Subject

Link

03-07-2019

Substance Evaluation: Two new conclusion documents are now available for:

Click here for more information about ECHA’s Substance Evaluation

03-07-2019

The European Union Observatory for Nanomaterials (EUON) has already available 340 unique substances/entries in its database

Click here for going to EUON’s database

11-07-2019

The General Court of the European Union published the Confirmation of the inclusion of Bisphenol A as a substance of very high concern on account of its properties as a substance toxic for reproduction

Click here for getting the official publication

 

Recent Updates Regarding CLP

 

Below table includes a summary of the main recent updates (non-exhaustive) regarding CLP Regulation (EC) No 1272/2008:

 

Summary of main recent updates

Date

Subject

Link

03-07-2019

New intentions to harmonise the classification and labelling:

 

New proposals to harmonise classification and labelling:

 

Registry of CLH intentions until outcome here

12-06-2019

Public consultations on harmonised classification and labelling:

 

The deadline for comments is 30th August 2019

Registry of CLH intentions until outcome here

 

Safety assessment of titanium dioxide for food contact materials

 

On 26th June 2019, the European Food Safety Authority (EFSA) published the scientific opinion: “Safety assessment of the substance, titanium dioxide surface treated with fluoridemodified alumina, for use in food contact materials”.

 

The Panel concluded that the substance does not raise safety concern for the consumer if used as an additive up to 25% w/w in polymers in contact with all food types for any time and temperature conditions. However, uses in polar polymers should be limited. The Panel emphasizes that the existing specific migration limits for aluminium and fluoride should not be exceeded in any case.

 

Click here for getting the safety assessment by EFSA.

 

US

 

Regulatory proposals notified to WTO

 

Below a summary table with some recent notifications to World Trade Organization (non-exhaustive):

 

Notification number / Link

Country

Title

G/TBT/N/USA/1494

US

Significant New Use Rules on Certain Chemical Substances

 

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 8 chemical substances which are the subject of premanufacture notices (PMNs)

 

US | Alaska

 

Anchorage, Alaska Approves Flame Retardant Ban

 

Anchorage Assembly unanimously passed Assembly Ordinance 2019-15(S), an ordinance that amends the Anchorage Municipal Code to add a new Chapter 15.100 and a new section which prohibits certain consumer products containing flame retardant chemicals.

 

Beginning from 1st  January 2020, no person shall manufacture, sell or distribute any upholstered or reupholstered furniture and juvenile products that contain, or a constituent component of which contain banned flame retardant chemicals exceeding 1,000 parts per million within the municipality including:

 

  • Halogenated, organophosphorus, organonitrogen, or nanoscale flame retardant chemicals
  • Penta or octa mixtures of polybrominated diphenyl ethers, the deca mixture of polybrominated diphenyl ethers (PBDEs), or decabromodiphenyl ether (decaBDE)
  • Antimony
  • Chemical listed as 'designated chemicals' under Section 105440 of the Health and Safety Code
  • Chemical covered in the Washington’s list of Chemicals of High Concern to Children

The following are not covered by this prohibition:

 

  • Used or second-hand products
  • Child restraint systems under 49 CFR 571
  • Electronic products, electronic components of upholstered or reupholstered furniture or juvenile products and any associated casing for those electronic products
  • Children's toys and clothing

Click here for the details.

 

US | Rhode Island

 

Rhode Island Increases Flame Retardants Levels in Upholstered Bedding and Furniture

 

On July 8, 2019, Rhode Island’s flame retardant Bill H 5119 (“An Act relating to health and safety- upholstered furniture and child products safety”) was signed into law by increasing the maximum amount of any non-polymeric organohalogen flame retardant chemical contained in residential upholstered bedding and furniture manufactured or sold in state from 100 ppm to 1,000 ppm.

 

Non-polymeric organohalogen flame retardant chemical includes any bromine or chlorine bonded to carbon chemical which is added to a plastic, foam, fabric, or textile. Following are exemptions from this rule:

 

  • Internal electric and electronic components of residential upholstered furniture
  • Bedding or residential furniture or bedding sold for use in commercial or public spaces

This act will come into force on 1st January 2020. The prohibition of unsafe children’s products will also apply from 1st January 2020. Products sold or in use prior to this date are not subject to this ban.

 

Click here for more information.

 

US | California

 

California Proposition 65 Reformulations (July, 2019)

 

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

 

In order to keep retailers and manufacturers up-to-date, the highlights of some recent consent agreements are summarized as below:

 

Product

Chemical

Limit

Case No

Test clip

Lead

DEHP

100 ppb

1000 ppm

Products that exceed the limit shall utilize a warning statement

Out of court

Batting Helmet-Face Guard

BPA

0.1 ppb

Products that exceed the limit shall utilize a warning statement

Alameda County Superior Court RG19010563

 

US | Vermont

 

Vermont Passes Children’s Products Reporting Rule Amendment

 

On 19th June 2019, Vermont governor signed Bill S.55 into law which amends the existing Chemicals of High Concern (CHCC) reporting rule.

 

CHCC reporting rule requires manufacturers of children’s products to report to the Vermont Department of Health if their product contains CHCC above the threshold from 1 January 2017. Following points are the major amendment of Act 188:

 

  • Manufacturers of children’s products containing a CHCC now shall provide notice to the Department of Health annually instead of biennially. The next reporting deadline will be due by 31st August 2020
  • Manufacturers of children’s products containing a CHCC now shall report the brand name, the product model, and the universal product code if the product has such a code

This amendment came into effect on 1st July 2019.

 

Document (PDF): [Vermont S. 55] in English.

 

Click here to access Health Vermont website.

 

Canada

 

Proposal of Formaldehyde Emissions from Composite Wood Products Regulations

 

On 29th June 2019, Canada published proposed Regulations for Formaldehyde Emissions from Composite Wood Products for indoor use which would align with similar requirements in the United States.

 

The proposed Regulations would establish the following maximum emission levels for formaldehyde emissions from composite wood products, the same limits as those in the U.S. regulations:

 

  • 0.05 parts per million (ppm) for hardwood plywood
  • 0.09 ppm for particleboard
  • 0.11 ppm for medium-density fibreboard
  • 0.13 ppm for thin medium-density fibreboard
  • 0.05 ppm for laminated products

Non-exempted composite wood products sold in, offered for sale in or imported into Canada, must be tested to ensure that they meet the above emission limits and are labelled as meeting the requirements.

 

This proposal would come into force six months after publication of the final Regulations in the Canada Gazette, Part II.

 

Click here for more information.