EU: Towards a Sustainable Chemicals Strategy of the Union, Policy Document, June 2019


On June 26, 2019 the Council adopted conclusions on chemicals which offer political guidance on the development of a sustainable EU chemicals policy strategy. The conclusions address the topics of REACH, endocrine disruptors, nanomaterials and pharmaceuticals.

In its conclusions, the Council underlines the need to protect human health and the environment through the sound management of chemicals. It also highlights the need to improve and mainstream the chemical risk assessment and management of chemicals across EU legislation in order to increase the coherence and effectiveness of EU chemicals-related legislation.

The conclusions highlight the need to develop a relevant mechanism for coordinating the protection of vulnerable groups such as children and pregnant and breastfeeding women. This should include the introduction of consistent risk management requirements into relevant EU legislation on substances of concern, including neurotoxins and endocrine disruptors.

Ministers call for the promotion of green and sustainable chemistry and non-chemical alternatives, and for the stimulation of research and service-based business models in this regard.

The Council underlines the need to support small and medium-sized enterprises in their efforts to replace substances of concern and stresses the right to information in order to enable consumers to make informed choices.

The Council also supports the development and implementation of an early warning system at EU level for identifying new, emerging chemical risks that will allow for appropriate action to be taken to protect human health and the environment.

The Council urges the Commission to develop, without further delay, a Union strategy for a non-toxic environment, that proposes clear objectives for a comprehensive long-term sustainable EU chemicals policy. It calls upon the Commission to include in its proposal for an 8th Environment Action Programme commitments to implement the follow-up measures to the Union strategy for a non-toxic environment and to address forward looking chemical related challenges. The Council also highlights the need for sustainable financing and resourcing of the European Chemicals Agency and calls for its involvement in other legislative areas.

The conclusions also address the following topics:

  • Pharmaceuticals: The Council stresses the importance to accelerate concrete and ambitious actions to reduce the risk from pharmaceuticals and their residues to the environment.
  • REACH: The Council calls upon the Commission and ECHA to develop by December 2019 an action plan on dossier compliance for REACH. The Council also stresses the importance of improving the REACH authorisation and restriction procedures.
  • Nanomaterials: The Council requests the Commission to extend ECHA’s mandate to collect and make available research data on the characterization, the hazard and potential exposure of nanoforms of substances that were so far not registered under REACH because their yearly tonnage is below the threshold of 1 tonne/year and to regularly ask ECHA to evaluate the performance and the impact of the EU-Observatory on Nanomaterials which was launched in 2017.
  • Endocrine disruptors: The Council urges the Commission to ensure a high level of protection of human health and the environment by minimising exposure to endocrine disruptors and by stimulating substitution by safer chemicals, as far as technically and practically possible, and to provide, without undue delay, an action plan with clear and concrete measures and an ambitious timeline for doing so.

Japan Regulation for NRMM or Non-Road Mobile Machinery

For AIAG suppliers who may provide parts into both markets, the NRMM and in-general equipment market will be heating up as they begin to fall under RoHS (Restrictions on Hazardous Substances) requirements. RoHS Annex IV has a Category 11 product type which is ‘everything else.’


Enacted in 2005, this Law aims to reduce emissions from non-road special motor vehicles and thereby protect the health of the people from air pollution and preserve their living environment, through the setting of technical standards for specified engines as well as non-road special motor vehicles and imposing necessary regulations on the use of non-road special motor vehicles, among other measures.

Non-road special motor vehicles are defined in Paragraph 2 of Article 2 of Road Vehicles Act (Act No. 185 of 1951), and emissions from non-road special motor vehicles refers to substances such as carbon monoxide, hydrocarbon and lead.

This law provides for obligations of manufacturers and importers of specified engines and non-road special motor vehicles such as conformity, marking and notification etc.

The notified business operators shall conform to technical standards for non-road special motor vehicles in respect to the type of notified non-road special motor vehicle concerned. The businesses must also compile an inspection record and preserve it pursuant to the provision of the Ordinance of the competent ministry.

Furthermore, when the notified business operator has complied with his duty as prescribed in this law, he/she may affix an indication as specified in the Ordinance of the competent ministry on the type of notified non-road special motor vehicle concerned.

This law entered into force on 1 April 2006.

China: Compulsory Certification of Motor Vehicles, Implementation Rules CNCA C11-01, 2014

This rule applies to motor vehicles of categories M, N and trailers of category O (including integrated or unintegrated) operating on highway and road in China.

Motor vehicles operating on railway, tractors for agriculture and forestry, all construction machinery and other motor vehicles not operating on road and chassis of category 3 are excluded.

This standard is written for the whole vehicle and the tests required to obtain certification. There are also standards for numerous individual automotive components. Certifying the individual components according to the CNCA automotive regulations is the preferred solution; otherwise, service parts imported into China may be detained by Chinese customs. In addition, according to the relevant CNCA automotive norms, these components cannot be marked with the CCC mark.

EPA Prioritization of 20 chemicals for TSCA

As required under the Toxic Substances Control Act (TSCA) and related implementing regulations, this proposed list initiates the prioritization process for 20 chemical substances as candidates for designation as High Priority Substances for risk evaluation and 20 chemical substances as candidates for designation as Low Priority Substances for risk evaluation. This document provides the identity of the chemical substances being initiated for prioritization, a general explanation of why the Agency chose these chemical substances and information on the data sources that EPA plans to use to support the designation.

EPA is providing a 90-day comment period (until June 19, 2019) during which interested persons may submit relevant information on these chemical substances.

Under the amended TSCA statute (section 6(b)(1)(B)) and implementing regulations (40 CFR 702.3), a High Priority Substance is defined as a chemical substance that EPA determines, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA. A Low Priority Substance is described as a chemical that EPA concludes, based on information sufficient to establish, without consideration of costs or other non-risk factors, does not meet the statutory criteria for designation as a High Priority Substance.

The EPA text from the Federal Register can be found at this link.

Public Consultation Launched on Chemical, Product and Waste Legislation

ACEA, CLEPA,  DIGITALEUROPE, ASD and other industry groups have issued a joint letter asking the EU Commission to allow stakeholder input on the proposed new Waste Frame Directive database as it’s being created.  They believe many benefits could be had from learning from IMDS and other formats being used in complex durable goods supply chains.  They also asked the Commission to take the below released report into consideration.  In the context of the Circular Economy Package, adopted in January 2018, the European Comm launched an Open Public Consultation (OPC) focused on options to address the interface between chemical, product and waste legislation, which ran from 23 July to 29 October 2018.

The questionnaire was divided in two parts: Part A aimed at gathering information on the company or organization represented by the respondent; Part B was organized based on the four main issues identified by the European Commission in the Communication and Staff Working Document on the interface that were published earlier in 2018. The questionnaire identified a number of challenges for each issue and posed questions (both multiple choice and open questions) aimed at collecting detailed information on specific topics.

This Public Consultation received 461 valid responses. 40 ad hoc contributions in the form of position papers were received separately. The replies were sorted and analyzed by category of stakeholder. Stakeholders were categorized as follows: Academic or Research Institutes/Educational Institutions (Academia); Non-governmental organizations (NGOs); Governments or public authorities (Governments); Other ; Businesses; and Industry or Trade Associations (Industries and Trade Associations). In addition, categories such as Businesses and Industries and Trade Associations included a versatile profile of respondents (recyclers, manufacturers, importers, etc.)

More information can be found at the Europa link here.


On 12 February 2019, the Commission joint Committee established under the REACH regulation, opened discussion on a proposal to amend Annex XIV of the regulation in order to list 12 additional new SVHC.

The proposal, which is based on ECHA 5th, 7th and 8th recommendations, will expand the REACH authorization list to 55 substances with sunset date up to 54 months after date of entry into force of the amended regulation.


All companies placing chemical substances onto the markets of the European Union and European Economic Area need to prepare for the United Kingdom’s withdrawal from the EU. New instructions are now available on ECHA’s website.

ECHA recommends companies to prepare for a ‘no deal’ scenario ahead of the UK’s withdrawal on 30 March 2019.

On 17 December 2018, the UK Government published a draft statutory instrument proposing to amend UK domestic waste regulations that implement certain European Directives related to waste management to ensure the continued operation of the UK waste regime post Brexit.

The draft focuses on ensuring that regulatory alignment with the EU continues with focus on waste batteries and accumulators, end of waste criteria, packaging waste, end-of-life vehicle destruction certification, landfill acceptance criteria, the management of waste from extractive industries, and calculation methods for verifying recycling target compliance.

The draft also aims to ensure that the rules set out under the following Directives continue to apply:

  1.  Directive 91/689/EEC on hazardous waste;
  2.  Directive 94/62/EC on packaging and packaging waste as amended by Council Regulation (EC) No 1882/2003;
  3.  Directive 2004/12/EC and Directive 2005/20/EC;
  4.  Directive 2008/98/EC on waste.

The draft, once enacted, will enter into force on 29 March with the exception of Part 1 and 2 which will enter into force 21 days after the text is finalized.

USA: Significant New Use of Certain Chemical Substances

EPA reopens the comment period for the proposed rule until October 30, 2018. Comments, docket EPA-HQ-OPPT-2017-0414  – must be received on or before October 30, 2018.

On August 17, 2018 EPA proposed significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 27 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action would require persons who intend to manufacture (defined by statute to include import) or process any of these 27 chemical substances for an activity that is designated as a significant new use by these rules to notify EPA at least 90 days before commencing that activity.

The SNUR primarily affects Alkanes, and declares as a “significant new use” of the designated chemical substances as Flame retardants and plasticizers in PVC, polymers, and rubber; flame retardants, plasticizers, and lubricants in adhesives, caulk, sealants, and coatings; additives in lubricants including metalworking fluids; and flame retardants and waterproofers in textiles.”

California (USA): Proposition 65 Implementing Regulations, 27 Cal.Code Regulations 25102 – 27000 – Amendment (on Article 6 Clear and Reasonable Warnings), Regulation, Article 6, 2017


The California Safe Drinking Water and Toxic Enforcement Act has been around since 1986; but the labeling requirements for manufacturers, retailers, and importers updated on Aug 31, 2018.  Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm.  These chemical can be in the products that are purchased, in homes or workplaces, or released into the environment.


25600.2. Responsibility to Provide Consumer Product Exposure Warnings
The manufacturer, producer, packager, importer, supplier, or distributor of a product may comply with this article either by providing a warning on the product label or labeling affixing a label to the product bearing a warning that satisfies Section 25249.6 of the Act, or by providing a written notice directly to the authorized agent for a retail seller who is subject to Section 25249.6 of the Act…

25603 Consumer Product Exposure Warnings

(a) Unless otherwise specified in Section 25607.1 et seq., a warning meets the requirements of this subarticle if it is provided using one or more of the methods required in Section 25602 and includes all the following elements:

(1) A symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline. Where the sign, label or shelf tag for the product is not printed using the color yellow, the symbol may be printed in black and white. The symbol shall be placed to the left of the text of the warning, in a size no smaller than the height of the word “WARNING”.
(2) The word “WARNING:” in all capital letters and bold print, and:

(A) For exposures to listed carcinogens, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to”
(B) For exposures to listed reproductive toxicants, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to”
(C) For exposures to both listed carcinogens and reproductive toxicants, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to”
(D) For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to”
(E) Where a warning is being provided for an exposure to a single chemical the words “chemicals including” may be deleted from the warning content set out in subsections (A), (B) and (D).

(b) A short-form warning may be provided on the product label using all the following elements:
(1) The symbol required in subsection (a)(1).
(2) The word “WARNING:” in all capital letters, in bold print.
(A) For exposures to listed carcinogens, the words, “Cancer –”
(B) For exposures to listed reproductive toxicants, the words, “Reproductive Harm –”

Proposed Prevention and Control of Environmental Pollution by Solid Waste Draft Law

On 11 July 2018, the Chinese Ministry of Ecology and Environment published a draft revision of the Law on Prevention and Control of Environmental Pollution by Solid Waste.

The draft consists of 102 articles in 6 chapters. Compared to the current law, the draft proposes amendments on 50 articles, adding 14 new ones and deleting 4. The main amendments focus on the following:

  • Prevention of second pollution during solid waste recycling and reuse in products
  • Reduction of the volume of waste landfill by reducing solid waste and increasing recycling
  • Strengthening the responsibility of the waste producer; establishing a solid waste discharge license system
  • Extension of manufacturer’s responsibility, encouraging manufacture to improve ecodesign, establish a recycle system and promote reutilization
  • Reform on solid waste import, in particular foreign waste import
  • Establishing domestic waste sorting systems
  • Improving hazardous waste management systems
  • Stricter penalties

Public comments may be submitted online before 18 August 2018