GPC Newsletter May-2021



Regulatory News

Final screening assessment and proposed risk management approach 

The Government of Canada under the Act of Canadian Environmental Protection Act (CEPA), has added selenium and 28 of its compounds to Schedule 1 (list of toxic substances).  For the Second Phase of CMP (Chemical Management Plan), some of the Selenium-containing substances are identified as priorities for Action.  

Its selection is based on the Categorization process that has been completed in 2006. Final screening assessment was performed on Substances with selenium moiety ie. on Selenium and its compound. It included substances containing Selenium in all oxidation states like Selenite, Selenate, elemental, selenide, etc and other Organic selenium and all forms of selenium found in the environment that met the categorization criteria and the same was added in Domestic Substance List as well and the same was added in Domestic Substance List as well. The assessment considered the combined exposure to all selenium compounds from natural or industrial sources, whether it is present in water, sediment, soil, air, food, or products available to consumers. 

The Government concluded that selenium and its compounds are harmful to human health, based on the potential for elevated levels in certain subpopulations in Canada; however, they are not considered harmful to the general population of Canada. They are also considered to have a harmful impact on the environment. 

Certain risk management actions have already been initiated by the Government to limit the exposure of these substances. It has been limited in certain uses, including in some foods and natural healthcare products. Following measures have been initiated: 

  • The Government lowered the maximum daily dose of selenium from 400 mg/day to 200 mg/day. 

  • Health risk assessments and opinions on the potential risks posed by chemical substances in traditional foods or in the interpretation of biomonitoring results will be provided by the Government. Any subsequent risk management advice developed from these assessments, such as issuing a consumption advisory, would be the responsibility of the relevant authority. 

  • the Government will continue to monitor the exposures of the general population to selenium through the Canadian Health Measures Survey 

The Schedule 1 listing gives government departments the authority to issue preventative or other control measures to manage potential health and environmental risks from the naturally occurring mineral. 

Last update: 2021-05-12

The Government of Canada evaluated the risks of PFOS, PFOA, and LC-PFCAs, and published the findings in screening assessment reports in 2006 and 2012. The PFOS, PFOA, and LC-PFCAs (and their salts and precursors) are prohibited through regulations in Canada; however, scientific evidence to date indicates the PFAS used to replace regulated PFOS, PFOA, and LC-PFCAs may also be associated with environmental and/or human health effects. These substances are predominately known for their composition of carbon-fluorine bonds. This kind of bond is so strong that it makes it difficult to degrade naturally. The Government of Canada has been conducting regular monitoring and surveillance of certain PFAS in terms of exposures from sources, including air, dust, water, products, and food.

The PFAS called the Per and Polyfluorinated substances are a large group of over 5000 human-made substances that have been used in firefighting foams, surfactants, cosmetic non-stick cookware, food packaging and stain-repellent fabrics, textiles, cosmetics and in other numerous areas. These substances are also referred as Forever chemicals because they remain for a longer time in the environment. Therefore, there are growing concerns about how they accumulate in both human and wildlife tissues. 

Adverse environmental and health effects have been observed for well-studied PFAS. Therefore, the Government of Canada intends to approach PFAS as a Single Class. A notice of intent to address the broad class of PFAS was published in the Canada Gazette, Part I: Vol. 155 No. 17 – April 24, 2021

With this background, the Canadian Government will continue to collect and examine information on PFSA to inform class-based approach and review policy development in other jurisdictions. They will publish various Reports which will contain information on PFAS Classification.  The input will be welcomed from the various stakeholders and interested parties. stakeholders are invited to provide initial feedback on the intent to address PFAS as a class, including challenges or opportunities they foresee or indicate their interest in being engaged in future discussions by emailing eccc.substances.eccc@canada.ca

Last year, ECHA continued addressing groups of structurally similar substances instead of assessing each chemical individually. This group approach boosted the total number of chemicals assessed in 2020 to around 1 900 – which is twice as many as in 2019 and ten times the amount screened annually between 2014 and 2018. 

From the group assessments concluded in 2020, 290 chemicals were identified as candidates for further EU regulatory risk management. Most of these will, however, require more data to be generated and confirmation of hazard before any actions can start. 

Harmonised classification is often a prerequisite for risk management actions under REACH or other EU legislation. There are over 100 substances identified, which based on currently available information, would warrant harmonised classification, but which have so far not been picked up by authorities. A lack of harmonised classification may delay risk management actions by companies or authorities. 

The group assessments have also shown that, based on the hazard and use information currently available, there is presently no need for further risk management at EU level for about two-thirds of the substances assessed. 

The progress made in clarifying the need for regulatory action for all registered substances above one tonne, can be followed through the chemical universe. 

Last update: 2021-05-25

Companies are recommended to register substances under EU REACH with an appropriate declaration of company size together with supporting documents in REACH-IT system.

Qualification of micro, small or medium-sized (MSME) enterprise is listed in the Commission Recommendation 2003/361/EC. If a company is under the category of MSME, they would need to check if the company size has been claimed before submitting registration.

If it is observed that wrong company size has been declared, then in that case all companies including Only Representatives (OR) acting on behalf of the non-EU company should inform ECHA proactively by emailing to: sme-verification@echa.europa.eu by 31 May 2021. Before ECHA begins the verification of company size, it is beneficial to declare and correct the company size which gives an advantage from a full administrative charge waiver (no admin fees penalty) and in that case company needs to pay the difference amount to the applicable registration fee. Otherwise, if ECHA finds the wrong company size after the verification process has started then, company will have to pay the balance of the correct fee and an administrative charge of up to EUR 19 900.  

It is important to regularly check your REACH-IT accounts for any messages and tasks from ECHA. Keep your registrations and your contact details up to date and react to ECHA’s requests.  

For further details kindly contact on sk@reach-onlyrep.eu

In a private communication with GPC, UK’s Health and Safety Executive (HSE) provided some clarification on the UK REACH compliance procedures currently available for importers and manufacturers.

A great number of GB-based importers and non-GB-based manufacturers are now taking advantage of the Downstream User Import Notification (DUIN) to maintain access to the GB market for their EU REACH registered substances, while postponing the registration deadline of these substances by 2, 4, or 6 years from 28 October 2021. Once they have submitted a DUIN, manufacturers and importers may submit an art. 26 Inquiry to HSE right away if they seek to claim the role of Lead Registrant (LR) or to simply be involved in the discussion to select a LR.

Following the successful submission of a DUIN and an art. 26 Inquiry, importers and manufacturers face two options:

  • Option 1: They may decide to register their substances right away. In this case, they must pay the HSE registration fee and submit a registration dossier. If all the substance information required in the dossier is not yet available to them, they may include a waiver explaining why they were not able to submit a full registration dossier (HSE is yet to publish guidance on acceptable justifications). They will them need to submit the full data by the relevant DUIN deadline (2, 4 or 6 years)
  • Option 2: They may continue to place their DUIN-notified substances on the GB market and wait to complete the full registration by the relevant deadline.

Despite its positive outcome (i.e., avoiding major disruptions on existing EU-UK supply chains), DUIN has had a tricky consequence for companies who seek to place EU-REACH registered substances into the GB market but who did not themselves place the substances on the GB market during the Brexit transition period (from 01/01/2019 to 31/12/2020). Indeed, new GB-based importers and non-GB-based manufacturers are required to register their substances within UK REACH before they may place them on the GB market. However, they are often unable to gather the substance information needed in the HSE registration dossier, because DUIN may have put the joint registrations and data sharing on hold.

Therefore, in order to provide parity between new registrants and DUIN beneficiaries, HSE recently introduced the concept of New Registration of an Existing Substance (NRES). If you are a non-GB based manufacturer or a GB-based importer and you seek to place an EU REACH-registered substance in the GB-market, then your substance qualifies as a NRES. Provided that you comply with a simplified registration process, you may place your substance on the GB-market and postpone the full registration deadline of your substance by 2, 4 or 6 years from 27 October 2021.

The simplified registration process is as follows:

  1. Submit an art. 26 Inquiry to HSE,
  2. Submit an alleviated registration dossier, including a waiver explaining why you were not able to submit a full registration dossier,
  3. Pay the HSE registration fee for your substance,
  4. You must then submit the full substance data by the relevant deadline (2, 4 or 6 years).

 

Last update: 2021-05-31

On 27th May 2021, three new Quality Control Orders (QCOs) were published in the Gazette of India, namely:  

  • The 3 (N, N Di-Ethyl) Aminophenol (Quality Control) Order, 2021 

  • The Methylene Chloride (Dichloromethane) (Quality Control) Order, 2021 

  • The Red Phosphorus (Quality Control) Order, 2021 

According to the three QCOs, goods and article containing 3 (N, N Di-Ethyl) Aminophenol, Methylene Chloride (Dichloromethane), and Red Phosphorus must conform to the relevant Indian Standards as shown in the table below. They must also bear the Standard Mark under a license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the BIS (Conformity Assessment) Regulations, 2018.  

Goods or articles 

Indian Standard 

Title of Indian Standard 

3 (N, N Di-Ethyl) Aminophenol 

IS 7686 : 2020 

Specification for 3(N, N-DiEthyl) Aminophenol - Specification 

Methylene Chloride (Dichloromethane) 

IS 4566 : 2020 

Specification for Methylene Chloride (Dichloromethane) – Technical 

Red Phosphorus 

IS 2012 : 2006, Reaffirmed 2016 

Red Phosphorus – Specification 

The three QCOs will come into force on the one hundred and eighty-first day following their publication in the Gazette of India, that is, somewhere around November 28th, 2021.  

Moreover, an amendment to the Morpholine (Quality Control) Order, 2020 was also published in the Gazette of India. The amendment postpones the entry into force of the Morpholine (Quality Control) Order to February 1st, 2022. 

 

Last update: 2021-05-31

India’s Ministry of Electronics and Information Technology (MeitY) published a draft policy paper Circular Economy in Electronics and Electrical Sector in May 2021. India is the third-largest consumer of raw materials produced globally. The electronics and electrical sector consumes various rare earth elements like iron, copper, silver, gold, aluminum, manganese, chromium, and zinc. With the current economic trends, the estimated material to be consumed is nearly 15 billion tonnes by 2030. This policy paper presents India’s ambition to preserve and enhance natural capital, to ensure products’ longer use-life, and to tackle challenges of products’ end of life (e-waste).  

This 48-pages policy paper draws upon existing regulations and policies that can be used as tools to facilitate a smooth transition to the circular economy. It also provides a roadmap for strategies that can be approached across products’ life cycle including raw material acquisition, product design, consumption, collection system, dismantling/recycling, and secondary material usage. This paper also indicates that the committee plans to draft the action plan with key measures across the value chain. On the national level, a National Circular Economy Council (NCEC), a multi ministry-level agency, is proposed to be in charge for promoting the circular economy in India. As a part of this Council, a roundtable with different stakeholders as well as industrial representatives will be invited. 

In a report published by the Ellen Macarthur Foundation in 2016, a circular economy development path in India could create an annual value of ₹14 lakh crore (US$ 218 billion) in 2030 and ₹40 lakh crore (US$ 624 billion) in 2050 compared with the current development scenario. By adopting circular economy approaches, businesses could achieve material cost savings and increase their profits, and could significantly mitigate negative environmental externalities. The foundation selected cities and construction, food and agriculture and mobility and vehicle manufacturing to analyze circular economy opportunities. 

In July 2020, at the EU-India summit, a joint declaration on India-EU Resource Efficiency and Circular Economy Partnership was published. The Partnership should support and strengthen cooperation between India and the EU on resource efficiency and circular economy in areas including building and construction, food, garment and textiles, the mobility sector, the Information, and Communication Technology (ICT) sector, renewable energy, circular business and service models, sustainable public procurement and waste management. 

The draft policy paper is available for public comments and suggestions latest by 31 May 2021. 

Ministry of Environment and Ecology of China (MEE) announced that the 3rd batch of chemical substance were added in the IECSC on 16 April. There were 204 chemical substances added this time. Since the announcement of MEE Order No.12, 459 chemical substances were added to the IECSC.  

According to the procedures settled in the ‘Notification of Improving the IECSC (SCC [2019] No.575)’, the inclusion of chemical substances into IECSC is decided by MEE based on the application submitted by individual parties such as companies and industry associations.

The recent partial amendment to K-REACH has been approved by South Korea's parliament on 13 April, and it will be enforced on 14 October. This amendment outlines the culpability of downstream users and resellers that employ unregistered substances. 

Chemical manufacturers and importers who use more than 100 kg of new substances every year, and more than 1 tonnes of existing substances every year obliged to register the substances before starting their business activities. Otherwise, they will face penalties or bans. 

The amendment included not only manufacturers and importers but also downstream users and sellers. In case of non-compliance, there may be risks of recall or ban. However, the detailed sanctions have not yet materialized. 

The amendment also enables the MoE to cooperate with other authorities such as the Customs Office so that the MoE can request import/export documentation concerning a specific substance.

Last Update: 2021-05-11

The Ministry of Environment (MoE) in South Korea updated the list of pre-registered substances, which in total becomes 17,096 substances. The list includes 1,800 substances that are manufactured and imported more than 1000 tpa and 78 CMR substances. The full registration deadline for these substances is by 31 December this year.

The MoE indicates no extension to the 2021 registration deadline though there was three months extension for 510 Priority Existing Chemicals (PEC) registration in 2018. 

Companies shall aim to complete full registration at least three months before the deadline as it might take some time to get a registration certificate due to a compliance check. The MoE regularly monitors pre-registration status e.g. tonnage band so that the companies can meet the deadline. 

 

Last update: 2021-05-11

On May 27 Taiwan’s Environmental Protection Administration (EPA) proposed an amendment to the Regulation on New and Existing Chemical Substances. The regulation was first published in 2014 and had previously been amended in March 2019. The legal basis for chemical registration in Taiwan is the Toxic and Concerned Chemical Substance Control Act (TCCSCA), which was enacted on 16 January 2019, amended, and renamed from Toxic Chemical Substance Control Act. The current chemical registration system has been in place since 1st January 2020.

To raise awareness in the chemical sector, Taiwan’s environmental authorities have brought an active conversation with stakeholders, notably by organizing public seminars. These seminars have provided stakeholders with key information on the obligation to register chemicals, as well as practical information on data submission. Taiwan’s environmental authorities expect individual chemical manufacturers or importers to prepare dossiers for standard registration (for chemicals listed in 106 Priority Existing Chemicals (PECs) list). Due to the COVID-19 outbreak, some of the seminars had to be postponed. Last month, EPA updated the fee structure for chemical registration by reducing fee for registrants who use non-animal testing alternatives and for those who need to extend the period of confidentiality.

It had been speculated that the EPA would move the registration deadline following concerns raised by manufacturing and importing associations over their members’ capacity to complete registration in time. Authorities then announced that they would give chemical manufacturers and importers sufficient time for data preparation. According to the recently published amendment, registrants will therefore have 4 years to complete their obligation for standard registration for 106 PECs. Companies that obtained Phase One Registration Code after January 1, 2020 are required to complete the Standard Registration (106 PECs) within four years. For the first batch of 106 PECs, the deadline to extended one more year to December 31, 2023 for quantity above 1 tonne per year. The valid CBI claims for New Chemical Substance is also extended to 5 years irrespective of tonnage.

The amendment also specifies that registration obligation of chemicals that are considered controlled chemicals and concerned chemicals are exempted from registration. The list of Controlled chemicals contains 19 chemicals and is regulated under the Regulations Governing Designation and Handling Permission of Controlled Chemicals. Before handling the Controlled Chemicals, a handler shall apply to the central competent authority for permission. No handling shall be commenced without permission. The list of controlled chemicals will be updated by the central competent authority from time to time.

Considering low exposure risk for onsite Isolated Intermediates, the amendment also changes the requirement for standard registration of new chemical substances under the category of onsite Isolated Intermediates. Standard registration is required only if the annual tonnage is above 10 tonnes. 

The amendment also confirms that registrant will be issued a registration number once they submit information in appendix 3 (one to seven item) and after these have been reviewed by the Authority. Hazard assessment and exposure assessment can be submitted at later stage as communicated by the authority.

Appendix 3: Information items to be submitted for Standard Registration:

  1. Information on the registrant and basic identification of the substance
  2. Information on manufacture, use and exposure of the substance
  3. Hazards classification and labelling
  4. Safe use information
  5. Physical and chemical properties
  6. Toxicological information
  7. Ecotoxicological information
  8. Hazard assessment
  9. Exposure assessment

The proposal for amending the draft of chemical substance registration is open for public consultation until July 26. GPC can forward your suggestions or feedback to the Taiwanese authority before the deadline.

The Law Bill 6.120/2019 is in possession of the Environment and Sustainable Development Commission (CMADS) of the Deputies’ Chamber since early December 2019, aiming to create the National Inventory of Chemical Substances in order to consolidate an information base on chemical substances produced or imported into the country.

After 15 months long waited, the legislation received a designated rapporteur only in March 2021 and had a five-meeting deadline for amendments established. After CMADS, the bill has three more commissions to go before enters into force. The Law Bill 6.120/2019 is expected to pave the way for a national chemical policy.

After the deadlines for amendments expired, only one amendment was presented in the Lower House. Supported by deputy Rodrigo Agostinho (former chairman of the environment committee of the Chamber of Deputies), the revision intends to bring back important aspects from the (National Committee on Chemical Safety) CONASQ’s proposal, present to the Congress in 2018 and shelved immediately when Bolsonaro’s government took place.

The modification highlights are related to the reestablishment of the Technical Committee for the Evaluation of Chemical Substances and the Deliberative Committee for Chemical Substances and rework the risk management, inspection, infractions, and sanctions activities.

Despite the gradual advancements, it is still uncertain when the proposal may be put to vote. If all three committees approve the bill, there is no president sanction needed.

 

Last update: 2021-05-30

At the XXII Meeting of the Forum of Ministers of Environment of Latin America and the Caribbean on 1-2 February 2021, ministries from six countries in Latin America announced the Action Plan 2021-2024 for Latin America and the Caribbean, aiming to promote regional cooperation towards sound management of chemicals and waste as initially established by the Action Plan 2019-2020.

The network (2021-2024) will focus on strengthening capabilities to review, apply, and enforce legal frameworks; share methodologies and capacities in the chemical assessments and in the elaboration of chemicals lists for control and monitoring; encourage full GHS adoption within public-private implementation; and stimulate a sustainable chemical industry to prevent and reduce the generation of hazard substance at the source.

The instruments under development will facilitate the implementation of a systematic compilation of information on production, trade, and use of substances, creation of a registry (notification and registration) of chemicals, an inventory of substances, and prioritize substances subjected to risk assessment.

Currently, only Chile implemented a national regulation for the classification, labeling, and notification of chemicals. Other countries including Argentina, Brazil, Colombia, Costa Rica, Peru, and Mexico are drafting their national legislations for the sound management of chemicals. A guideline is under elaboration by the Latin American Regulatory Cooperation Forum (LARCF) to support national implementation in Latina America. It is expected to be published by March 2021.

last update: 2021-05-20

The Latin American Regulatory Cooperation Forum (LARCF), coordinated with the International Council of Chemical Associations (ICCA), published the Roadmap for the Rational Management of Industrial Chemical Substances and Products in late April 2021. The project involved government representatives, industrial associations, and industries from 11 countries in Latin America, including Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Mexico, Panama, and Peru.

The document provides an overview of the basic elements that compose the rational management of chemical substances. It includes and step-by-step approach to develop a national plan for chemical management, further implement GHS standards, establish a chemical inventory, and perform risk evaluation and prioritization. This roadmap presents increased interest in the region to enhance its chemical management system. Another chemical initiative in the region is UNEP’s Action Plan 2021-2024 for Latin America and the Caribbean.

This document can be seen as increased regional cooperation and engagement on chemical management system. More detailed national regulations for chemicals can be expected in Argentina, Colombia, Brazil, Costa Rica, Mexico and Peru in the near future.

The importance of the document surpasses the proposed activities, it shows the true national-regional engagement in adopting safer policies for chemicals. A gradual implementation of national regulation for chemicals is expected since six countries (Argentina, Brazil, Colombia, Costa Rica, Mexico, and Peru) are elaborating their future national chemical legislation in the region.

Last update: 2021-05-20

In a meeting held in May 19-20, 2021 (SGT 6), the Mercosur Environment Working Subgroup recommended advancing the regulatory framework within the bloc. The proposal includes the adoption of an updated GHS version and a regulatory harmonization among countries, although a proper version was not defined.

Mercosur is composed of four countries: Argentina, Brazil, Paraguay, and Uruguay. Brazil and Uruguay adopted GHS 4th version, Argentina implemented the 5th, and Paraguay has to endorse the system.

In Latin America, the arrangement on chemical control (GHS, inventory, notification, and registration) is on the surge. Six countries (Argentina, Brazil, Colombia, Costa Rica, Peru, and Mexico) are developing their future national chemical legislation; meanwhile, Chile recently approved its regulation for the classification, labeling, and notification of hazardous chemicals and mixtures in February 2021.

The implementation of GHS is usually seen as one of the first steps for a country to enhance its chemical management system. The recently published Roadmap for the Rational Management of Industrial Chemical Substances and Products shows increased regional cooperation within countries in Latin America is on the way.

Last update: 2021-05-20

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