Eurofins | Newsflash - January 2019 | Chemicals
New phthalates restriction and scope expansion under REACH Annex XVII (Entry 51)
On 18th December 2018, Commission Regulation (EU) 2018/2005 was published in the Official Journal of the European Union.
This new regulation amends Entry 51 of Annex XVII to REACH Regulation (EC) No 1907/2006 as regards bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP).
Previously, only three phthalates (DEHP, DBP, BBP) were restricted in plasticised materials in toys and childcare articles under this Entry 51.
The new amendment introduces the following 2 major changes:
- Inclusion of Diisobutyl phthalate (DIBP) restriction, in addition to DEHP, DBP and BBP, in toys and childcare articles
- Scope expansion: not only toys and childcare articles are included in the scope of the restriction of these 4 phthalates (DEHP, DBP, BBP, DIBP), but also any plasticised materials in articles. List of articles excluded from this restriction is included in Paragraph 4 of this new amended Entry 51, within which we can find:
- Measuring devices for laboratory use
- Materials and articles intended to come into contact with food within the scope of Regulation (EC) No 1935/2004 or Commission Regulation (EU) No 10/2011
- Medical Devices
- Electrical and electronic equipment within the scope of RoHS Directive 2011/65/EU
As indicated in the new Entry: ‘Plasticised material’ means any of the following homogeneous materials:
- Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC),polyvinyl acetate (PVA), polyurethanes
- Any other polymer (including, inter alia, polymer foams and rubber material) except silicone rubber and natural latex coatings
- Surface coatings, non-slip coatings, finishes, decals, printed designs
- Adhesives, sealants, paints and inks
These additional restrictions under REACH Annex XVII Entry 51 will become effective from 7 July 2020.
Excessive levels of phthalates in toys
Every week European alerts about Phthalates in toys and other children’s products are published in RAPEX (Rapid Alert System for dangerous non-food products).
A joint customs and market surveillance operation by different EU countries took place during the last quarter of 2018. The inspections focused on plasticized toys (especially dolls).
The result was quite worrying: more than a third of inspected samples with CE marking in their packaging contained phthalates in concentrations exceeding the limits under REACH Annex XVII Entry 51 and 52.
Click here for watching the European Commission conference on REACH, CLP and biocides.
New requirements nanomaterials registration
On 4th December 2018, the following regulation was published in the Official Journal of the European Union:
“Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances”
The European Commission has adopted the revision of several Annexes of REACH Regulation including new registration requirements for nanomaterials that will be applied from 1st January 2020.
Click here for getting the Official Journal of the European Union.
Click here for more information from European Commission website.
Click here for reading the ECHA’s news.
Recent Updates Regarding REACH
Below table includes a summary of some additional recent updates (non-exhaustive) regarding REACH Regulation (EC) No 1907/2006:
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Summary of main recent updates |
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Date |
Subject |
Link |
|
December 2018 |
Commission Implementing Decision (EU) 2018/2013 of 14 December 2018 on the identification of 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one (3-benzylidene camphor) as a substance of very high concern pursuant to Article 57(f) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council. |
Click here for getting the official publication in the Official Journal of the European Union. |
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December 2018 |
European Commission has notified to World Trade Organization (WTO) the following draft with reference G/TBT/N/EU/630: “Draft Commission Regulation (EU) amending Annex V to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)”. |
Click here for getting the official publication in the European Commission website. |
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December 2018 |
ECHA invited to Importers and EU producers of articles to check if the following substances in their articles meet the conditions for notification. The deadline for submitting substance in articles notifications for below 10 substances of very high concern added to the Candidate List in June 2018 was 27 December 2018:
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Click here for more information from ECHA’s website. |
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December 2018 |
The European Chemicals Agency (ECHA), has recently launched a public consultation on the draft opinion of SEAC (Committee for Socio-Economic Analysis) regarding a REACH Annex XV dossier proposing restriction of certain chemicals in tattoo inks and permanent make-up. The deadline for submitting comments is 11 February 2019. |
Click here for more information from ECHA’s website. |
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December 2018 |
Public consultation of draft recommendation for amending the Authorisation List (Annex XIV) entries for the following phthalates to include their endocrine-disrupting properties:
The deadline for comments is 12th March 2019. |
Click here for more information from ECHA’s website. |
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December 2018 |
Public consultations about proposed restrictions of five cobalt salts and of N,N-dimethylformamide. |
Click here for more information about Submitted restrictions under consideration. |
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November 2018 |
Q&As on UK withdrawal from EU updated In January 2019, ECHA will provide technical guidance for UK-based companies on how to notify ECHA through REACH-IT of changes related to appointing an only representative based in one of the remaining EU-27 Member States. To take this into account, the Agency has updated Q&As 1445, 1464 and 1466 on its web pages on the UK’s withdrawal from the EU. |
Click here to review the updated Q&As. |
Recent Updates Regarding CLP
Below table includes a summary of the main recent updates (non-exhaustive) regarding CLP Regulation (EC) No 1272/2008:
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Summary of main recent updates |
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Date |
Subject |
Link |
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December 2018 |
European Commission has notified to World Trade Organization (WTO) the following draft with reference G/TBT/N/EU/629: “Draft Commission Regulation amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting Commission Regulation (EU) 2018/669” The purpose of this draft Regulation for a 14th adaptation to technical progress of Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures (the CLP Regulation) is to amend table 3 to Annex VI of the CLP Regulation by introducing new or revised entries for the harmonised classification and labelling of 28 substances and by removing 2 substances. It also amends Annexes II and III to the CLP Regulation by defining specific labelling obligation for mixtures containing titanium dioxide. Lastly, the classification of the substance pitch, coal tar, high temp. is corrected.
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Click here for getting the official publication in the European Commission website. |
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December 2018 |
Public consultation on the harmonised classification and labelling: The deadline for comments for the following substances is 8th February 2019:
The deadline for comments for the following substances is 15th February 2019:
The deadline for comments for the following substances is 22nd February 2019:
The deadline for comments for the following substances is 1st March 2019:
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Public consultation on harmonised classification and labelling here. |
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December 2018 |
Proposals to harmonise classification and labelling for:
Intentions to harmonise the classification and labelling for:
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Click here for the Registry of CLH intentions until outcome. |
Recast of Persistent Organic Pollutants Regulation: on-going journey
On 22nd March 2018, the European Commission adopted a proposal to recast the regulation on persistent organic pollutants.
On 15th November 2018, the European Parliament adopted amendments on the proposal.
At its meeting of 28th November 2018, the Council agreed its position on the proposal.
Negotiations have already been initiated within the different institutions but no agreement has been reached between the Parliament and the Council at this time. New trilogue will be scheduled for January or February 2019.
Click here for getting the press release regarding European Council position.
Click here to access the Legislative Train Schedule.
ECHA’s brief guidance on treated articles
ECHA has recently published a brief guidance regarding treated articles under Biocidal Products Regulation: “What you need to know about treated articles”.
This guidance includes brief information about:
- Treated article vs. not treated article
- Types of treated articles according to their biocidal properties
- Labelling of treated articles
- Transitional measures
- Consumers’ right to ask
Further information about Treated Articles at ECHA’s website here.
Standards Updates
Below a summary table with some 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.
(**) Date of availability: date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat.
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Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
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Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics.
This European Standard specifies the European Standards to which products have to conform in order to support the claims for microbicidal activity which are referred to in this European Standard. This European Standard also specifies terms and definitions which are used in European Standards. It is applicable to products for which activity is claimed against the following microorganisms: vegetative bacteria (including mycobacteria and Legionella), bacterial spores, yeasts, fungal spores and viruses (including bacteriophages). It is intended to: a) enable manufacturers of products to select the appropriate standards to be used in order to provide data which support their claims for a specific product; b) enable users of the product to assess the information provided by the manufacturer in relation to the use for which they intend to use the product; c) assist regulatory authorities in assessing claims made by the manufacturer or by the person responsible for placing the product on the market. It is applicable to products to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas. |
2019-05-31 |
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Reference |
Title |
Date of Availability (**) |
Supersedes |
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Chemical disinfectants and antiseptics - Differentiation of active and non-active substances.
This document defines how to exclude or confirm that an excipient in a biocidal product is an active substance within the frame of the European Biocidal Product Regulation and other regulations. |
2018-11-14 |
- |
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Steels and cast irons - Determination of substances listed in the directives 2011/65/EU (RoHS) and 2000/53/EC (ELV) – Limitations. |
2018-11-14 |
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Nanotechnologies - Guidelines for Life Cycle Assessment - Application of EN ISO 14044:2006 to Manufactured Nanomaterials. |
2018-12-05 |
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Practical guides for consumer products
Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes (DGCCRF) has published a guide about chemicals, biocides and detergents as below (in French):
Persistent Organic Pollutants (POPs) Regulation
On 14th November 2018, Persistent Organic Pollutants (POPs) regulation was published in Turkey.
It contains seven annexes on the restrictions and management of POPs.
- Prohibited substances list (Annex 1)
- Restricted on its own, in mixtures or articles (Annex 2)
- List of substances subject to emission reduction (Annex 3)
- List of substances subject to waste management (Annex 4)
- Waste management (Annex 5)
- Notification forms (Annex 6 and 7)
The scope and requirements of this new Turkey legislation are very similar to the ones in EU POPs Regulation (EC) 850/2004 but with some differences such as acceptable limits for some chemicals, within others.
As an example of the differences with EU legislations, it is relevant to emphasize that Turkey has included Decabromodiphenyl ether (DecaBDE, CAS 1163-19-5) as a restricted substance under Annex 2 of this new regulation, while in EU, DecaBDE is restricted under REACH Annex XVII (Entry 67) with differences in scope and requirements.
Some relevant chemicals listed under Annex 2 (substances subject to restriction) of this new Turkish regulation are listed below (non-exhaustive):
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Substances |
Requirement |
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Tetrabromodiphenyl |
≤ 10 mg/kg in substances, mixtures, articles or parts thereof for each of the substances listed in the first column.
Exceptionally, the following shall be permitted to be manufactured, used and marketed:
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Pentabromodiphenyl |
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Hexabromodiphenyl |
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Heptabromodiphenyl |
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Decabromodiphenyl |
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Perfluorooctane sulfonic acid and its derivatives (PFOS) |
≤ 0.001% in substances or mixtures |
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< 0.1% in semi-finished products or articles, or parts thereof |
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< 1 μg/m² in coated textiles or materials |
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Hexabromocyclododecane (HBCDD) and its main isomers (α-, β- and γ-HBCDD) |
≤ 100 mg/kg in substances, mixtures, articles or parts thereof |
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Short chain chlorinated paraffins (C10-C13, SCCP) |
< 1% in substances or mixtures |
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< 0.15% in articles |
Click here to access the Resmi Gazete No. 30595.(in Turkish)
Proposition 65: Amendments regarding responsibility to provide consumer products exposure warnings
From 16th November to 31st December 2018, Office of Environmental Health Hazard Assessment (OEHHA) opened a public consultation about a proposal to amend Title 27, California Code of Regulations, section 25600.2, subsections (b), (c) and (f), Responsibility to Provide Consumer Product Exposure Warnings.
The aim of these proposed amendments is to clarify the regulatory provision implementing the statutory direction to place the primary obligation for providing a Proposition 65 warning on the product manufacturer, thus minimizing the impact of the warning requirements on the retail seller.
Click here for more information about this public consultation from OEHHA’s website.
California Proposition 65 Reformulations (December, 2018)
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:
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Product |
Chemical |
Limit |
Case No |
|
Polymer exercise balls |
DBP |
1000ppm Products exceed the limit shall utilize a warning statement. |
Los Angeles County Superior Court BC658596 |
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Alife vinyl travel accessory and accessory strap products and product in that product category/type |
DEHP, DBP, BBP, DINP, DIDP, DnHP |
1000ppm Products exceed the limit shall utilize a warning statement. |
Marin County Superior Court CIV 1704288 |
Flame Retardant Bill on Juvenile Products, Upholstered furniture and mattresses – Enacted!
On 29th September 2018, California’s flame retardant Bill AB 2998 was approved by Governor and, therefore, already enacted.
From January 1, 2020, it is prohibited to sell or distribute in California any new juvenile products, mattresses, or upholstered furniture containing covered flame retardant chemicals or a constituent component at levels above 1,000 parts per million.
Covered flame retardant chemicals means any chemical whose functional use is to resist or inhibit the spread of fire including one of the following:
- A halogenated, organophosphorus, organonitrogen, or nanoscale chemical
- A chemical defined as a “designated chemical” in Section 105440 of the Health and Safety Code
- A chemical covered in the Washington’s list of Chemicals of High Concern to Children
“Juvenile product” means a product designed for residential use by infants and children under 12 years of age, including, but not limited to, a bassinet, booster seat, changing pad, floor playmat, highchair, highchair pad, infant bouncer, infant carrier, infant seat, infant swing, infant walker, nursing pad, nursing pillow, playpen side pad, playard, portable hook-on chair, stroller, and children’s nap mat. Some products not included in “Juvenile product” definition are listed in the Bill.
The prohibitions in this ban do not apply to the following:
- Electronic components of juvenile products, mattresses, reupholstered furniture, upholstered furniture, or any associated casing for those electronic components
- Upholstered or reupholstered furniture components other than those identified in paragraph (1) of subdivision (a) of Section 19094
- Thread or fiber when used for stitching mattress components together
- Components of adult mattresses other than foam
The text of Assembly Bill No. 2998 (AB 2998) can be found here.
Oregon Amends the PQLs for Chemicals of Concern list
On 7th December 2018, Oregon Health Authority (OHA) approved a Permanent Administrative Order PH 280-2018 amending the Practical Quantification Limits (PQLs) for High Priority Chemicals of Concern for Children's Health (HPCCCH) under Toxic-Free Kids Act.
Under the Toxic-Free Kids Act, manufacturers must provide biennial notice to OHA of children's products sold in Oregon that are covered by the Oregon Toxic-Free Kids Act and contain HPCCCH in the final product that are intentionally added at or above practical quantification limits (PQL).
The PQL for a chemical that is a contaminant is 100 parts per million. The practical quantification limits for intentionally added chemicals are the limits established in Exhibit A.
The new Administrative Order PH 280-2018 amends OAR 333-016-2035 Exhibit A by adding PQLs corresponding to the five HPCCCH added to OAR 333-016-2020 on September 2018, and removing PQLs for the three HPCCCH delisted also on September 2018. (Check our Eurofins News Flash November 2018 edition for further information on the September 2018 rulemaking mentioned above).
This amendment is effective from January 1, 2019. Click here for more details.
Plan to restrict 2 flame retardants and 3 oil and water repellents
In October 2018, the Government of Canada published in its Gazette the “Notice of intent to amend the Prohibition of Certain Toxic Substances Regulations, 2012”.
In this notice, it is indicated that the Department of the Environment and the Department of health are initiating the development of amendments to the “Prohibition of Certain Toxic Substances Regulations, 2012” to further restrict the manufacture, use, sale, offer for sale and import of two flame retardants (HBCD and PBDEs) and three oil and water repellents (PFOS, PFOA and LC-PFCA).
Click here to access the Canada Gazette.
