China MIIT published Catalogue of Demonstration Guide for Key New Materials (2019)

On 25 November 2019, China MIIT published Catalogue of Demonstration Guide for Key New Materials (2019).

In 2016 China MIIT established an insurance compensation mechanism to promote the production and application of new materials in industry, and which would benefit companies using these listed materials. The scheme requires the regular release of an application demonstration guidance directory for key new materials, and the construction of a new material production and application demonstration platform. This platform is intended to reduce the risk to downstream users and improve the efficiency of insurance compensation work.

This catalogue covers 331 types of new materials that widely used in different industries and products. The industries and products include, among others: vehicles, new energy vehicles, pressure vessels, chemical industry, IT equipment, medical devices, 3D printers, textiles.
The 331 types of materials are separated into advanced basic materials, key strategic materials and cutting-edge new materials.

The advanced basic materials cover the following types of materials:

  • Advanced Steel Materials;
  • Advanced Nonferrous Metals;
    • Aluminium
    • Magnesium
    • Titanium
    • Copper
    • Other Nonferrous Metals
  • Advanced Chemical Materials;
    • Special rubber and other polymer materials
    • Engineering plastics
    • Membrane material
    • New electronic chemical materials
    • Other advanced chemical materials
  • Advanced Inorganic Nonmetallic Materials;
    • Special glass and high-purity quartz products
    • Green building materials
    • Advanced ceramic powder and products
    • Artificial Crystal
    • Mineral Functional Materials
  • Rare metals;
  • High-performance targets materials;
  • Other new materials.

Key strategic materials cover the following types:

  • High-performance fibres and composite materials,
  • Rare earth functional materials,
  • Advanced semiconductor materials and new display materials,
  • New energy materials.

This 2019 catalogue entered into force on 1 January 2020.

EU Packs 19 and 20, Consultation request for New and Renewal RoHS Annex IV for DEHP, Lead and Cadmium


The scope of the current consultation concerns two exemption requests: one for exemption renewal and one for a new exemption.

The application for the renewal of exemption 12, Annex IV was submitted under the project “Pack 19”, the application for the new exemption is being evaluated under the project “Pack 20”. The requests of both packages are to be consulted upon together, under the current stakeholder consultation.

Oeko-Institut and Fraunhofer IZM, on behalf of the European Commission, has published the requests as worded by the applicant, therefore the applicant is solely responsible for the wording and supporting evidence it has provided.

How to submit a stakeholder contribution

The following general guidelines should be taken into account:

• Refer to the exemption request listed in Table 2-1 and have a clear reference as to the exemption number

• Take the questionnaires on the exemption requests into account (questionnaires available under the exemption request specific pages, accessible through this link, and select exemptions through the tabs on the left.)

• Clearly state whether the exemption requests are supported or whether no justification is apparent. To support your contribution, it is required to provide relevant technical and scientific evidence in accordance with the criteria listed in Article 5(1)(a). Explain the reasons why potential alternative materials, designs or processes are unsuitable with quantitative data wherever possible. If possible, provide photographs or diagrams to illustrate claims. Provision of third party data and information may be beneficial to further support your view. Sources of information should be referenced where possible.

• Provide your input to the consultation as early as possible in order to allow other stakeholders to comment.

• Exemptions to RoHS Directive cannot be justified on the basis of confidential information.

New RoHS Stakeholder Consultation

This article was authored by Mike Kirschner of Design Chain Associates. 

Last week the Öko-Institut opened up a new stakeholder consultation on the three remaining substances proposed for restriction under the RoHS Directive:

  • Antimony Trioxide (ATO; a synergist for halogen-based flame retardants);
  • Medium-chained chlorinated paraffins (MCCPs) – Alkanes, C14-17, chloro; and
  • Tetrabromobisphenol-A (TBBPA)

Öko-Institut’s bottom line and rationale for these three substances is interesting but not unexpected.

ATO: if ATO on its own is restricted, there is a risk of regrettable substitution since – as a consequence of this restriction – an increased amount of halogenated flame retardants is expected to be used, bringing along their predominant negative impacts on health and the environment. In order to avoid this, the consultant proposes not to exclusively restrict ATO, but instead to carry out an assessment of the system of halogenated flame retardants and the ATO synergist with high priority.

MCCPs: Öko-Institut recommends restricting a range of MCCPs, describing that this entry covers chlorinated paraffins containing paraffins with a chain length of C14-17 – linear or branched.

TBBPA: it is recommended to include this substance in the list of restricted substances with a limit value of 0.1 % per weight due to the described risks of TBBP-A and the availability of alternatives. Assuming good and controlled manufacturing conditions, reactive applications and in particular its use as a component of FR4 PWB would not be affected by this restriction, because the residual levels of TBBP-A would be below the proposed limit in this case.

Note that, In light of the upcoming ban of organohalogen flame retardants (OHFRs) in displays/monitors/TVs under the Eco-design Directive, as well as the relatively non-impactful restriction of TBBPA, this should be interesting. In my opinion, in order to effectively restrict ATO, they have to restrict the entire sub-class of OHFRs that ATO would be used with in polymers including PVC and others.

Not to be too overshadowed, another stakeholder consultation is concurrently open on “substance prioritization” for 43 substances that could represent upcoming restriction proposals under RoHS. Öko-Institut is asking for quantitative usage data on these 43 substances.

Both stakeholder consultations are open until January 30, 2020.

EU: Detailed Information Requirements for the SCIP Database, Report, September 2019

This document presents an overview of the information requirements for the database organized by following the conceptual data model (Section 2); it provides further clarity on the approach taken for the design of the SCIP database to all interested parties, namely duty holders and REACH and Waste Member State Competent Authorities.

The conceptual model provides a basis for the implementation of the SCIP database on articles containing Candidate List substances under the Waste Framework Directive envisaged by ECHA.

The conceptual model of the database:

1. Provides a high level view on the scope of the information / data to be stored in the database;
2. Establishes key relationships between the main entities within the database’s scope;
3. Clarifies key concepts.

The mandatory information requirements for the database consist of all the data fields which need to be filled in by the duty holders when preparing their notifications. The optional fields may be filled in on a voluntary basis.

The information requirements, which define the content of the database, have been developed based on legal requirements and consultations with the European Commission, Member States and stakeholders. Suppliers of articles need to provide:

  • information that allows the article to be identified;
  • the name, concentration range and location of the SVHC in the article; and
  • possibly other information on the safe use of the article.

The SCIP database will provide waste operators with information about the hazardous substances in the waste they process so that material streams can potentially be “cleaned” before recycling and reused in the production of new articles to ensure a true and safe circular economy.

In addition, the increased transparency on the presence of hazardous substances will help consumers to make better informed choices when purchasing products and provide information on how to best use and dispose of such articles.

China: Public Consultation on Production, Use and Replacement of Six Persistent Organic Pollutants (POPs), Draft Announcement, September 2019

On 18 September 2019, the Chinese Ministry of Ecology and Environment (MEE) opened a public consultation to collect from the industry, information on the production and use of six persistent organic pollutants (POPs).

The proposal aims to further align with the prohibition or restrictions of these substances under the Stockholm Convention. The substances are:

  • short-chained chlorinated paraffins (SCCPs),
  • decabromobiphenyl ether (DecaBDE),
  • polychlorinated naphthalenes (PCN),
  • hexachlorobutadiene (HCBD),
  • pentachlorophenol (PCP) and its salts and esters,
  • perfluorooctanoic Acid  (PFOA) and its salts and related compounds.

Relevant stakeholders are required to submit to the MEE by e-mail ( before 31 October 2019 information regarding the:

  • state of production and use of these substances,
  • possibility of the immediate discontinuation of production and use for purposes other than specific exempted ones
  • suitability of ending production and use for specific exemption use in the next 5 years, and
  • suitability of control of these substances release into the environment

EU REACH: Four New SVHCs Proposed

Authored by: Dr. Paul Goodman, Principal Regulatory Consultant, RINA

The European Chemicals Agency has proposed four substances to be added to the REACH Candidate List as Substances of Very High Concern (SVHC). Three of the substances are reported to be reproductive toxins and the fourth (PFBS) is a possible endocrine disrupting substance, harmful to the environment and humans, as well as being fairly persistent.

The current Stakeholder Consultation, ending on the 18th October 2019, aims to confirm whether the substances meet the Article 57 criteria for addition to the Candidate List, e.g. if they are category 1A or 1B reproductive toxins. Details on the substances and typical uses are as follows:

  • 2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone (CAS 119313-12-1): This substance is used as a photoinitiator added to UV curable inks, toners, adhesives, resins, paints and other coatings. It may also be used in fillers and adhesives. It is used in the manufacture of many products including electronic equipment. This substance is added typically at 0.5 to 5% of the cured material which may be a coating on an article or printed ink and so the concentration in simple articles (as defined by REACH) could be less than 0.1% by weight. However, when it is used as a thicker section of cured polymer the concentration it is more likely to exceed 0.1% of the article.
  • 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (CAS 71868-10-5): This is a photoinitiator added to UV curable inks, toners, lacquers, paints and resins. It may also be used in solder masks and etch resists in glass fibre composites. It is used at similar concentrations to 2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone so may occur at <0.1% in thinly coated articles, but when used as a thicker section it is more likely to exceed 0.1% of the article.
  • Diisohexyl phthalate (CAS 71850-09-4): This is another dialkylphthalate that has been added to the Candidate List. Dihexyl phthalate is already listed. This substance is a plasticiser so may occur in flexible polymers and rubbers, inks, lacquers and sealants. It is also reported to be used in vehicle steering fluids and in auto transmission lubricants.
  • Perfluorobutane sulfonic acid (PFBS) and its salts (No unique CAS number as it is group of substances): These substances are used as water soluble surfactants and in stain and water resistant coatings (including as a substitute for perfluoroctyl sulphonate – PFOS, which is now banned in many countries).

If these substances are determined to be eligible to be added to the Candidate List, they could be added with the next update to the Candidate list due in January 2020.

Inclusion of Bisphenol A in REACH Candidate List – as a Reproductive Toxin


Bisphenol A is a substance which is mainly used as an intermediate in the manufacture of polymers. It is also used for non-intermediate purposes for the manufacture of thermal paper. On 19 July 2016, the Commission adopted a regulation1 under which Bisphenol A is classified as toxic for reproduction.

In accordance with the relevant procedure, the French National Security Agency for Food, Environmental and Occupational Health and Safety presented the European Chemicals Agency (ECHA) with a dossier concerning Bisphenol A in which it is stated that that substance is used for non-intermediate purposes but that it is not that substance’s sole use. ECHA’s Member State Committee, after having met, unanimously decided to identify Bisphenol A as a substance of very high concern meeting the criteria set out in Article 57(c) of the REACH Regulation2. On 4 January 2017, the Executive Director of ECHA adopted a decision whereby Bisphenol A was included in the list of substances identified for eventual inclusion in the list of substances subject to authorisation referred to in Article 59(1) of the REACH Regulation.

The association, PlasticsEurope, represents the interests of manufacturers and importers of plastic products in the European Union and, inter alia, four companies active in placing Bisphenol A on the market. According to that association, in adopting the contested decision of 4 January 2017 without explicitly excluding intermediate uses from the inclusion of Bisphenol A in the candidate list of substances, ECHA infringed the REACH Regulation. It complains that ECHA breached the principle of proportionality and committed a manifest error of assessment by failing to take into consideration information on the intermediate uses of Bisphenol A. It therefore brought an action for annulment before the General Court against the decision of the Executive Director of ECHA of 4 January 2017.

In today’s judgment, the General Court notes that a substance used as on-site isolated intermediate or as a transported isolated intermediate is not automatically exempted from all the provisions of the REACH Regulation. Such a substance does not, therefore, escape the identification procedure provided for in that regulation. The exemption laid down in Article 2(8)(b) of the REACH Regulation concerns only the authorisation procedure. By contrast, the regulation does not preclude a substance from being capable of being identified as being of very high concern, even though it is used merely as an on-site or transported isolated intermediate.

The General Court notes, furthermore, that nothing obliged ECHA to insert, in the ‘candidate list of substances’, an explicit reference to the fact that intermediate uses were not covered by the inclusion of Bisphenol A in that list.

The General Court points out that one of the objectives of the candidate list of substances is the establishment of information sharing obligations in respect of substances of very high concern within the supply chain and with consumers. The identification of a substance as a substance of very high concern serves to improve information for the public and professionals as to the risks and dangers incurred. The General Court therefore considers that the contested decision is consistent with the objective of sharing information on substances of very high concern within the supply chain and with consumers. It finds that the legal effects of that decision do not go beyond what is appropriate and necessary to achieve that aim.

Lastly, the General Court considers that the use of a substance as an intermediate is not relevant, since the information relating to that use does not concern the intrinsic properties of that substance whereas the identification and inclusion of a substance in the candidate list of substances are carried out solely on account of the intrinsic properties of a substance and not on account of the uses of that substance.

The General Court therefore dismisses the action in its entirety

NOTE: An appeal, limited to points of law only, may be brought before the Court of Justice against the decision of the General Court within two months and 10 days of notification of the decision. The appeal will not proceed unless the Court first decides that it should be allowed to do so. Accordingly, it must be accompanied by a request that the appeal be allowed to proceed, setting out the issue(s) raised by the appeal that is/are significant with respect to the unity, consistency or development of EU law.

NOTE: An action for annulment seeks the annulment of acts of the institutions of the European Union that are contrary to European Union law. The Member States, the European institutions and individuals may, under certain conditions, bring an action for annulment before the Court of Justice or the General Court. If the action is well founded, the act is annulled. The institution concerned must fill any legal vacuum created by the annulment of the act.

EU: RoHS Directive 2011/65/EU -Proposed Amendment- (exemption for lead in solders and termination finishes used in certain hand-held combustion engines) Draft Directive, Aug 2019


“In Annex III to Directive 2011/65/EU, entry 41 is replaced by the following:

41. Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of handheld combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council *)

Applies to all categories and expires on:

  • [the last day of the 24th month after the publication of this Delegated Directive in the Official Journal] for categories 1 to 7, 10 and 11;
  • 21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
  • 21 July 2023 for category 8 in vitro diagnostic medical devices;
  • 21 July 2024 for category 9 industrial monitoring and control instruments.”

EU: How to Comply with NMP (1-methyl2-pyrrolidone) Restriction, Guidance Document, July 2019

A document released by ECHA intends to help those who use 1-Methyl-2-pyrrolidone (NMP) or mixtures containing NMP (C ≥ 0.3%) , to comply with the restriction requirements under the REACH Regulation. Moreover this guidance may help the authorities to understand what is expected and evaluate the compliance at a site.

NMP has a harmonised classification as toxic to / for reproduction (reproductive toxicant category 1B) and is also a respiratory, skin and eye irritant. In Europe, NMP is subject to REACH Annex XVII restriction 71. If you have to use NMP in your workplace, you need to protect anyone that could be exposed to it. This guideline is intended to help you understand what you need to do to comply with the provisions of this restriction in its own right but also against the background of your existing occupational safety and health (OSH) obligations.

The general approach described in this guideline can be applied to other aprotic solvents similar to NMP (such as DMF and DMAC), if similar REACH restrictions are introduced for other aprotic solvents. Some elements of the guideline are NMP specific (e.g. good practice examples, monitoring methods, description of uses etc.) and therefore may not be directly applicable to other substances.”

A new guideline is available for industrial users of 1-methyl-2-pyrrolidone (NMP) to help them comply with the substance’s restriction requirements. The guideline is needed because this is the first restriction of its kind that is based on Derived no Effect Levels (DNEL).

NMP is used as a solvent or surface deposition medium during manufacturing and is therefore a critical substance for various industries producing batteries, semiconductors, fibres, pharmaceuticals and wire coatings. NMP users in these sectors will have to comply with the restriction by 9 May 2020. For NMP used in wire coatings, the deadline is 9 May 2024.

In close cooperation with stakeholders, ECHA has prepared the guideline to help companies, including SMEs, to manage the risks when using NMP at industrial sites. NMP is a reproductive toxicant (may damage the unborn child), it causes serious eye and skin irritation and it may cause respiratory irritation. Several consultations and round table workshops have been organised to identify good practice and find illustrative examples on how users of NMP can control exposure to NMP and comply with the restriction.

The general approach described in this guideline can also be applied to other aprotic solvents similar to NMP, such as DMF and DMAC, if similar REACH restrictions are introduced for other aprotic solvents at a later stage.

The document can be found at this link.

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.