The EU Commission has reacted to calls from industry associations (see: Poison Centers: ECHA Opens Submission Portal for Hazardous Mixtures), and prepared a new draft regulation. According to the draft, the reporting period for mixtures used by consumers is being moved from January 1, 2020 to January 1, 2021.
Furthermore, the draft indicates that the unique formula indicator (UFI) would then be required only on safety data sheets (SDS) and no longer be required on the label of hazardous mixtures delivered to industrial users. For deliveries of unpacked hazardous mixtures, the UFI must be given on the SDS or on a copy of the label that accompanies the material. Modifications and additions are also planned for product identifiers, applicants, and concentration ranges.
The draft regulation will be discussed in the next CARACAL meeting on July 1–2 in Brussels. It could then be adopted in September or October.
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The Asia-Pacific Economic Co-Operation (APEC) community, representing 21 nations and almost half the world’s population, has advised its members to adopt the GHS 7th revision uniformly by the end of 2021 to harmonize its requirements across member states. The goal of the community is to simplify trade in one of the world’s fastest-growing economic areas.
Along with the adoption of GHS 7th revision, APEC recommends that its members:
- Provide flexibility when classifying building blocks
- Participate in the APEC regulator forum when it defines hazard categories and thresholds
As part of a survey, APEC has developed an overview of the status of the GHS in individual countries and published the results in its APEC CD GHS Implementation Convergence Questionnaire 2019 Progress Report. The APEC Web site provides further information, including appendixes with progress reports. The following countries participated in the survey:
- Russian Federation
- United States
Most countries have already implemented GHS revision 3 and 4. Six countries (Canada, Malaysia, Russia, Singapore, Taiwan, and the United States) plan to implement GHS 7th revision but have not indicated if they will do so by 2021. In early June, Australia announced a consultation on accepting GHS 7th rev.
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The Nordic Council of Ministers, which has supported collaboration between Denmark, Finland, Iceland, Norway, and Sweden since 1971, has provided small and midsize companies with a free online tool that they can use to register nanomaterials according to REACH. The Danish Environmental Protection Agency made the announcement in a press release (in Danish only).
According to the announcement, the tool, e-REACHNano, was jointly funded by a working group of the Nordic Council of Ministers on chemistry, environment, and health and by DHI, an international software development and engineering consultant firm.
The three core elements of the tool are nanomaterials, the related risks, and the implementation of REACH. Several videos explain the contents.
The current version is to be updated his year to consolidate the requirements that are to apply as of January 2020.
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On May 22, 2019, the EU Commission published Regulation (EU) 2019/831 that modifies Annexes II, III and V of Regulation (EC) No. 1223/2009 in the Official Journal of the EU. The modifications include the addition of 226 carcinogenic, mutagenic, or reproductive toxic substances to Annex II of the Cosmetics Products Regulation.
With the modifications, the EU, as noted under Section 3, is seeking uniform implementation of the prohibition of CMR substances within the internal market, assurance of legal certainty, especially for economic operators and national competent authorities, and assurance of a high level of protection of human health.
The EU imposed further limitations on the use of CMR substances in textiles only in October 2018. At the beginning of May 2019, it published a glossary of common ingredient names of contents for use in cosmetics labels.
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In the future, the ECHA wants to check four times as many REACH dossiers as it currently does. That’s the information the Agency provided in a press release. According to REACH, Article 41, Point 5, the ECHA is obligated to check 5% of REACH dossiers for conformity with the law in terms of the data the dossiers contain. Accordingly, the Agency examined about 2,700 dossiers for compliance over the past 10 years.
The action plan that the ECHA wants to publish in June 2019 calls for checking all registered chemicals with a tonnage band greater than one ton by 2027. Action is still needed, as shown in the ECHA report published at the end of February. According to the report, three of every four dossiers inspected are incomplete.
The German REACH Compliance Project reached a similar conclusion. The German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung: BfR) worked with the Federal Environment Agency (Umweltbundesamt: UBA) to examine more than 3,800 REACH dossiers and reached a sobering conclusion. In tonnage bands greater than 1,000 tons, more than every third dossier did not conform with the law. For tonnage bands of 100 to 1,000 tons, almost every fifth dossier was non-compliant.
In its announcement, the ECHA emphasizes that it is not authorized to refuse access to the market to companies that fail to comply with their legal obligations for specific chemicals. That’s much more a matter for national authorities. In his appeal, ECHA director Björn Hansen repeatedly called on nations and the companies responsible to act. In his article in the ECHA Newsletter (2-2019), he emphasized the importance of sound chemical data, saying “ultimately, industry can only implement the right risk management measures if they have the right data.”
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The German Olympic Sports Confederation (Deutscher Olympischer Sportbund: DOSB) and the German Football Association (Deutscher Fußballbund: DFB) have issued a position paper (German only) that criticizes the upcoming ban on the use of plastic granules for synthetic turf and calls for a transition period of at least six years.
In January 2019, the European Chemicals Agency (ECHA) published the Annex XV Restriction Report that suggested restricting microplastic according to Annex XV of REACH (1907/2006/EC). The report calls for the regulation to prohibit the marketing of “intentionally added” microplastics as of 2021. However, the ECHA does support longer transition periods for some usages. However, the agency did not suggest a longer period for artificial turf granules because the sector did not provide it with any information during development of the report.
The sporting associations have now reacted and call for a six-year transition period. The time is needed, they say, to overhaul the more than 6,000 installations of artificial turf in Germany. Faster implementation of a ban would force the closure of many sports facilities.
What happens now? Public consultation on the ECHA restriction proposal runs until September. In the upcoming months, the risk assessment committee (RAC) and the socio-economic analysis committee (SEAC) will respond to the proposal.
The granules are seen as critical (German only) because an estimated 95% of the fill material is from recycled tires that contain polycyclic-aromatic hydrocarbons (PAH), some of which are classified as carcinogenic, mutagenic, or toxic to reproduction. That’s why last year, the ECHA worked with the Netherlands to develop a proposal on limiting the concentration of eight PAHs.
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Argentina is in the process of defining minimum standards for dealing with industrial chemicals. Elisa Coghlan, who is responsible for Argentinian chemicals management, told Chemical Watch that Argentina wants to proceed in stages. The first stage would involve the creation of a national directory of chemicals. In the following stage, a committee of experts would evaluate the risks posed by these chemicals and prioritize responses.
The Ministry for Environment and Sustainable Development (Ministerio de Ambiente y Desarollo Sustenable: MAyDS), or, more exactly, the Department for Chemical Substances and Products (D. de Sustancias y Productos Quimicos) is responsible for setting up chemical management. For a good overview, see the organizational chart of the ministry (all sites given here in Spanish only).
The legal context of the future law covers the following:
- Creation of a national chemical inventory
- Provisions for new chemicals and uses
- Creation of evaluation committees
- Clarity on risk assessment and risk management
- Provisions for dealing with confidential business information (CBI)
- Setting administrative fees, fines, and administrative sanctions for non-compliance
According to UN Environment, the Argentinian chemicals industry is the second-most important in Latin America, after Brazil. It contributes 12.3% of the gross national product and employs about 110,000, mostly in small and midsize companies.
KFT has served companies in South America for many years and is thoroughly familiar with the laws related to chemical compliance. Please contact us at firstname.lastname@example.org.