Eurofins | Newsflash - March 2019 | Chemical
Final version of guidance on poison centres notifications
On 5th March 2019, the European Chemicals Agency (ECHA) published the final version of Guidance on harmonised information relating to emergency health response – Annex VIII to CLP.
This document provides guidance on the provisions of Article 45 and Annex VIII to CLP Regulation (EC) 1272/2008. These concern the obligation to submit certain information on hazardous mixtures placed on the market, for emergency response reasons.
This document is available on ECHA’s website.
New Amendment to the EEA Agreement
On 7th February 2019, the European Commission published “Decision of the EEA Joint Committee No 89/2017 of 5 may 2017 amending Annex II (technical regulations, standards, testing and certification) to the EEA agreement [2019/201]”.
In this amendment, “Commission Regulation (EU) 2017/227 of 9 February 2017 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 bis(pentabromophenyl)ether” is added into the EEA Agreement, so that the text of this regulation amending REACH in Icelandic and Norwegian languages shall be authentic.
Click here to get the European Commission publication.
Proposal position on Persistent Organic Pollutants
In February 2019, the European Commission published the two following position proposals on Persistent Organic Pollutants:
- Proposal for a COUNCIL DECISION on the position to be taken on behalf of the European Union at the ninth meeting of the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants as regards the proposals for amendments of Annexes A and B. COM(2019) 52 final 2019/0025(NLE)
- Proposal for a COUNCIL DECISION on the submission, on behalf of the European Union, of a proposal for the listing of methoxychlor in Annex A to the Stockholm Convention on Persistent Organic Pollutants. COM(2019) 82 final 2019/0039(NLE)
The position shall support:
- The listing of the following substances in Annex A to the Convention:
- Dicofol (without specific exemptions).
- Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds (with specific exemptions)
- Methoxychlor
- The deletion and amendment of the listed “acceptable purposes” and “specific exemptions” from the entry on perfluorooctane sulfonic acid (PFOS) and its derivatives in Annex B to the Convention
Approaching date for phthalates under RoHS 2
From 22nd July 2019, Directive (EU) 2015/863 amending Annex II to RoHS Directive 2011/65/EU regarding the restriction of four phthalates will be effective.
After this date the following restricted substances shall not be allowed in electrical and electronic equipment:
|
Restricted substances |
Maximum concentrations VALUES TOLERATED by weight in homogeneous materials (%) |
|
Lead |
0.1 |
|
Mercury |
0.1 |
|
Cadmium |
0.01 |
|
Hexavalent chromium |
0.1 |
|
Polybrominated biphenyls (PBB) |
0.1 |
|
Polybrominated diphenyl ethers (PBDE) |
0.1 |
|
Bis(2-ethylhexyl) phthalate (DEHP) |
0.1 |
|
Butyl benzyl phthalate (BBP) |
0.1 |
|
Dibutyl phthalate (DBP) |
0.1 |
|
Diisobutyl phthalate (DIBP) |
0.1 |
Note: The restriction of DEHP, BBP and DBP shall not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through Entry 51 of Annex XVII to REACH Regulation (EC) No 1907/2006.
Other important remarks:
- The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitromedical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021
- The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021
Plastic additives initiative is a joint project of the European Chemicals Agency (ECHA) and industry launched in 2016. The aim of this project is to “characterize the uses of plastic additives and the extent to which the additives may be released from plastic articles”.
The project has lasted two years (2016-2018) and, as a result, an overview of over 400 additives in plastics used in high volumes in the EU has been generated. The project included the development of a method for comparing the release potential of the different additives. This method could be used by companies in order to check if registration dossiers should be updated or if improvement should be made on the communication of safe use information down the supply chain.
Click here to access the ECHA’s Mapping exercise – Plastic additives initiative.
Click here to get Supplementary Information on Scope and Methods by ECHA.
Click here for more information about Comparing relative release potential method.
Update draft of Single-Use Plastics Directive
On 18th January 2019, the Council of the European Union published an amendment (5483/19 ) of the draft Directive on the reduction of the impact of certain plastics products on the environment (Single-Use Plastics Directive).
Recent Updates Regarding REACH
Below table includes a summary of some additional recent updates (non-exhaustive) regarding REACH Regulation (EC) No 1907/2006:
|
Summary of main recent updates |
||
|
Date |
Subject |
Link |
|
January 2019 |
ECHA published a new practical guide on how to report changes in identity under REACH and CLP. |
Click here for more information. |
|
February 2019 |
Corrigendum to the Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006. (OJ C 30, 24.1.2019) (2019/C 47/08). |
Click here for more information. |
|
February 2019 |
On 15th February 2019 the European Commission notified to World Trade Organization the Draft Commission Regulation amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). This draft Commission Regulation aims at amending Annex XIV of the REACH Regulation. Annex XIV lists the substances which are subject to the authorisation requirement laid down in Title VII of the Regulation. The draft proposes to include 12 additional substances in that Annex. |
Reference: G/TBT/N/EU/643. |
|
February 2019 |
A summary of the ECHA’s strategic plan for 2019-2023 is available on ECHA's website. |
Click here to read the “in brief” document. |
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 |
|
February 2019 |
Leaflet on CLP now available in 23 languages |
CLP leaflet here. |
|
February 2019 |
Public consultation on the harmonised classification and labelling: The deadline for comments for the following substances is 22nd March 2019:
|
Public consultation on harmonised classification and labelling here. |
|
February 2019 |
Proposals to harmonise classification and labelling for:
New intentions for:
|
Click here for the Registry of CLH intentions until outcome. |
Is Bisphenol P a safe alternative?
On January 2018, the substance 2,2-bis(4'-hydroxyphenyl)-4-methylpentane, also known as Bisphenol P, was added in ECHA’s candidate list of substances of very high concern (SVHCs) following the proposal from the Swedish Chemicals Agency (Kemikalieinspektionen – KEMI).
Restriction proposal for intentionally added microplastics
On 30th January 2019, the European Chemicals Agency (ECHA) published the health and environmental risks assessment report about intentionally added microplastics.
On 5th February 2019, the European Commission has published the following amendments to Directive 2011/65/EU (RoHS) as below, regarding exemptions for lead and cadmium.
Amendment of specific diffuse waste requirements of the Code of the Environment
On 15th January 2019, France published the Order of January 15, 2019 amending the order of August 20, 2018 relating to the approval procedure and the terms of reference of the eco-organizations of the sector of specific diffuse waste (DDS) household, for the case of categories 3 to 10 of chemicals designated in Article R. 543-228 of the Environment Code.
In accordance with the principle of Extended Producer Responsibility (EPR), the management of household DDS resulting from the chemicals designated in Article R. 543-228 of the Environment Code must be ensured by the producers of the said products. To fulfill their obligations, the latter must set up either an individual approved system or join an eco-organization holding an accreditation. This aims to optimize the management of this waste, to improve the treatment, but also to prevent the production of waste, including the ecodesign of these products.
This decree makes an editorial clarification of the specifications annexed to the Decree of August 20, 2018 which sets the conditions that the approved eco-organizations must respect.
Click here for getting the official publication in Legifrance.gouv.fr website.
Practical guides for distance selling of chemicals, biocidal products and detergents
The French “Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes“ (DGCCRF) has published an article about the distance selling of chemicals, biocidal products and detergents and which information should be made available to consumers before buying the product.
Click here for reading the DGCCRF article (in French).
New requirements for treated wood
On 11th January 2019, France published the Order of 18 December 2018 on the restriction of use and placing on the market of certain treated wood.
This decree lays down the prohibition of the placing on the market of treated wood, whether or not treated wood is imported, new or reused.
It provides derogation and temporary provisions for creosote-treated wood for use in railways and as electricity or telecommunications poles.
This decree also specifies the treatment to be applied to treated wood waste.
Do it yourself’ (DIY) products project- chemical substances
A recent Danish Environmental Protection Agency project checked the safety of some products used in ‘do it yourself’ (DIY) works. The project examined products commonly used in DIY renovation projects in the home and looked at whether they pose health risks due to exposure to hazardous substances.
After initial screening, the project team chose to examine the risks of nine products in more detail (paints, waxes, chemical wood products, joint foam, white spirit). Eight of the nine products tested were shown to pose some risks to human health if used without appropriate safety equipment such as protective gloves or respiratory masks during application.
Many of the observed concerns were related to products which can release volatile compounds.
Click here for more information about the DIY project from Danish Environmental Protection Agency website.
Approval of animal test ban
On 22nd February 2019, the Australian Department of Health published the notice about the approval of The Industrial Chemicals Bill 2017 with its amendment by the Senate (on 14 February 2019) and The House of Representatives (on 18 February 2019).
As already announced in our Eurofins News Flash February 2019 edition (Cosmetics), the main amendments are:
- The new scheme, the Australian Industrial Chemical Introduction Scheme (AICIS);
- The ban on the use of new animal test data for ingredients solely used in cosmetics will also begin on 1 July 2020
It is currently awaiting Royal Assent by the Governor-General to become Australian law.
The Second Step of China’s RoHS will enter into effect on March 12, 2019 for selected EEPs in first Batch
On March 12th 2018, the Ministry of Industry and Information Technology (MIIT) issued "The Standard Management Catalogue of Limiting the Use of Hazardous Substances in Electrical and Electronic Products (EEPs) (first batch)" and "the Exemption List to the Use of Restricted Substances in the Standard Management Catalogue". These two standards are used to implement the second step of Management Methods (Management Methods for Restricted Use of Hazardous Substances in Electrical and Electronic Products).
The Management Methods adopt a two-step approach:
- As a first step, a declaration of hazardous substances is required if the concentration of restricted substances in the products is over the limits.
- As a second step, the products that are included in “The Standard Management Catalogue of Limiting the Use of Hazardous Substances in Electrical and Electronic Products” have to be subject to concentration limits for hazardous substances except those in the Exemption List.
Besides this, Article 18 of the Management Methods points out that the authorities will develop a “conformity assessment system” that manufacturers will have to follow in order to comply with the requirements, but it has yet to be formalised.
From March 2019, these two standards will come into force.
EEPs categories in first Batch include*:
- Refrigerators (cubage ≤ 800 L)
- Air conditioners (rated refrigerating capacity ≤ 14000 W)
- Washing machines (rated washing capacity ≤ 10 kg)
- Electric water heaters (cubage ≤ 500 L)
- Printers (printing format ≤ A3 and printing speed ≤ 60 sheet/min)
- Copiers (printing format ≤ A3 and printing speed ≤ 60 sheet/min)
- Fax machines
- Televisions
- Monitors
- Microcomputers
- Mobile communication devices
- Telephones
* These product categories are described in the scope of the conformity assessment scheme of hazardous substances in electrical appliances and electronic products. It is the finished product which will define the applicability of the catalogue. The catalogue states that the listed products are out of scope when used as part of other products which are not listed. However, when products are not clearly identified for end use and are sold separately, they fall within the scope of this catalogue.
Restricted hazardous substances**:
- Lead and lead compounds (0,1 %)
- Mercury and mercury compounds (0,1 %)
- Cadmium and cadmium compounds (0,01 %)
- Chromium VI compounds (0,1 %)
- Polybrominated biphenyls (PBB) (0,1 %)
- Polybrominated diphenyl ethers (PBDE) (0,1 %)
** Similar to the EU RoHS Directive, some applications are exempt from the substance restrictions.
Applicable standards (Including amendments) for all EEPs
- Labelling – SJ/T 11364-2014
- Requirements of concentration limits – GB/T 26572-2011
- Test methods – GB/T 26125-2011, GB/T 29783-2013
- Specifications for technical documentation - GB/T36560-2018
California Proposition 65 Reformulations (February, 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 |
|
Glass rain gauges with exterior designs |
Lead |
90 ppm Products exceed the limit shall utilize a warning statement. |
Sacramento County Superior Court 34-2018-00231892 |
|
Salt and pepper shakers |
Lead |
90 ppm 1.0 ug Products exceed the limit shall utilize a warning statement. |
Out of court |
Public consultation on Ketones
On 19th January 2019, the Canadian Government published the “Draft screening assessment Ketones group” and “Risk management scope for ketones specifically 2-butanone (MEK); 4-methyl-2-pentanone (MIBK); 2,4-pentanedione (2,4-PD)”.
With these two reports the Canadian Government highlights the danger of these substances and it is waiting for the final assessments by January 2020.
If the final assessment confirms the conclusion of the draft, these substances would meet the criteria of section 64 of the Canadian Environmental Production Act (Cepa) and the Government would be obliged, under Cepa, to take risk management measures against these chemicals.
The Canadian Government has opened a public consultation on MEK, MIBK and 2,4-PD which will finish by 20th March.
