GPC Newsletter Apr-2021

Hello! 

GPC is proud to announce new “Monthly Newsletter Podcast” 

Stay up to date on changing compliance regulations is important for you as business owners. New standards and requirements are always being implemented and enforced as the business expands to more countries and regions. GPC has compiled a list of global regulatory news with our international team to ensure you and your colleagues can stay up to date on the latest and most relevant compliance requirements. 

We are aware that with the progress of technology, it is becoming easier to communicate with different parts of the world in a split second but meanwhile it made our days busier. To be able to keep on the grid, listening can be one of the best and quickest ways to stay up to date. This is why GPC is now providing you the latest global regulatory news with the new monthly podcast! 

In future episodes, we will include short interviews with our regulatory team and external guests to provide you better insight into the updates. If you have any ideas or feedback about our new podcast series, please feel free to tell us so we can improve!

  • Open Spotify app on your smartphone
  • Tap on the search tab and then the search bar
  • Tap on camera icon on top-right of the screen
  • Scan the code and start listen and don't forget to follow us!



Regulatory News

Under the New Substance Program, Environment and Climate Canada and Health Canada are responsible for administering the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). Recently, the Canadian government published the Guidelines for the Notification and Testing of New Substances were prepared to assist individuals responsible for complying with the New Substances Notification Regulations (NSNR) under the Canadian Environmental Protection Act, 1999(CEPA, 1999). There is a time-to-time amendments in the Domestic Substance List and Non-Domestic Substance List. Non-Domestic Substance list updates are based on the US EPA’s TSCA Chemical Substances Inventory. 

 

Guidance Document is meant to help notifiers determine whether a substance is subject to a notification under the regulations or not and to identify the information requirements for the notification.  

 

In addition to the above it provides, 

  • step-by-step instructions for the completion of a New Substances Notification (NSN); 

  • user-friendly flowcharts to aid in determining the appropriate schedule to file. 

  • technical considerations of the information requirements. 

  • detailed instructions on how to complete the New Substances Notification Form; 

  • identification of appropriate test procedures and practices to use; and 

  • an outline of how confidential information should be submitted. 

 

Comments provided by June 30, 2021 will be taken into consideration during the development of the final Guidance Document. Comments can be submitted using the online reporting system available through Environment and Climate Change Canada’s Single Window or by email to eccc.substances.eccc@canada.ca. In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information may submit, with the information, a request that it be treated as confidential. Comments received will be considered when developing the final Guidance Document, which is expected to be published late 2021. 

The draft Guidance Document can be found here.  

Last update: 2021-04-21

As per Canada’s New Substances Fees Regulations, fees must be provided with each New Substance Notification (NSN) package submitted under the New Substance Notification Regulations (Chemicals and Polymers).  The amount of fee will be dependent on the annual sales in Canada for the notifier, the specific Schedule being submitted, and other services being requested (e.g., confidential search on the Domestic Substances List or Non-Domestic Substances List or masked name application).   

Environment and Climate Change Canada has implemented this fee adjustment for the New Substances Program to be in compliance with Canada's Service Fees Act which requires annual fee adjustments based on the country’s Consumer Price Index (CPI). Based on the decrease in CPI over the past twelve months, fees for NSN submissions will decrease by 0.2% starting from April 1, 2021 and it will be valid till March 31, 2022. 

The New Substances program consists of officials from Environment and Climate Change Canada and Health Canada. It is responsible for administering the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) [NSNR] made under the Canadian Environmental Protection Act, 1999 (CEPA). These regulations ensure that no new substances (chemicals, polymers or living organisms) are introduced into the Canadian marketplace before undergoing ecological and human health assessments, and that appropriate control measures have been taken, wherever required. 

To pay for services stated above, a complete New Substances Fees Payment Form, including a credit card authorization form, must be sent either by mail or by courier or one can use the Fee Payment phone line at 1-833-225-2883 (in Canada) or 819-994-8167 (outside Canada). 

All federal departments and agencies that collect fees for regulatory and non-regulatory services are required to develop and implement a Departmental Remissions Policy by April 1, 2021. Each program that charges fees is also required to establish a remissions approach that aligns with the Departmental Remissions Policy. 

The Remissions Approach by New Substances Program (NSP) sets out the scope and application for remission payments, regulatory timeline or non-regulatory performance standard be missed by the NSP.  

Last update: 2021-04-21

 

 

On April 14, 2021, ECHA recommends for the European Commission to add seven substances to the Authorisation List (Annex XIV of REACH). Once on the list, companies will need to apply for authorisation to continue using them.

The seven substances are:

  • the cyclosiloxanes D4
  • the cyclosiloxanes D5
  • the cyclosiloxanes D6
  • Terphenyl, hydrogenated
  • DCHP
  • Disodium octaborate
  • TMA

The European Commission together with the EU Member States and the European Parliament will take the final decision to include these substances of very high concern (SVHCs) in the Authorisation List. After the decision is published, the date by when companies will need to apply to ECHA for authorisation to continue using the substances will also be announced.

The reason why the cyclosiloxanes D4, D5 and D6 were prioritized by EACH from the Candidate List is that they are hazardous and are usually produced in high volumes and widely used. Some uses of the cyclosiloxanes are already restricted or in the process of being restricted in consumer products and in most professional uses under REACH. The cyclosiloxanes have been prioritised for inclusion in the Authorisation List as some of their uses, for example, industrial production of electronics and some professional uses such as dry-cleaning in closed systems, are not covered by the restriction activities. 

Terphenyl, hydrogenated is used as a heat transfer fluid mainly in industrial installations as well as in adhesives, sealants, coatings, inks and paints and can also be found in some plastic articles. 

For substances DCHP, disodium octaborate and TMA, they are recommended to be in the Authorisation List because there are similar chemical structures that can be used.

 

Last update: 2021-04-14

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In an email exchange with GPC dated April 2nd, 2021, HSE provided a much-welcomed clarification regarding the requirements that non-GB manufacturers must meet in order to qualify for DUIN.

In their email, HSE stated that DUIN is only available for companies that imported/used EU REACH-registered substances into Great Britain (GB) in the two years before the end of the Transition Period (1st January 2019 - 31st December 2020). Alternatively, a non-GB manufacturer may submit a DUIN via a GB-based Only Representative (OR) in order to maintain access to the British market. In this case too the availability of DUIN is conditioned upon the substance being placed on the British market in the two years before the end of the Transition Period.

On the opposite, if a substance is imported into Great Britain after the end of the Transition Period as part of a new supply chain, then the criteria to submit a DUIN are not met. The importer will therefore be required to carry out the full registration of the imported substance, unless the non-GB based manufacturer of that substance appoints a GB-based OR to fulfill that obligation on behalf of the importer.

Last update: 2021-04-05

The entry into force date of Eurasia REACH has been postponed. The regulation was initially planned to come into force on 2nd June 2021.  This postpone is mainly due to the delay of the approvement of the second part of Eurasia REACH regulation in which contains the following information:

  • The procedure for the formation and maintenance of the EAEU register of chemical substances.
  • The procedure for the notification of New Chemicals.

The authorities underline that a new date for regulation’s entry into force will depend on whenever the second part of the regulation will be approved. Without this, the regulation cannot come into force.

In February this year, a draft of the second part of the regulation was published for public discussion on the EAEU Commission’s website. Many industries expressed and submitted their comments to the EAEU Commission before the deadline on 1st of April 2021.

The EAEU Commission is expected to review the commentaries and approve the second part of the regulation in the near future. When this happens, a new entry into force date of Eurasia REACH will be released.  

In early April, the Department of Chemicals & Petrochemicals under the Ministry of Chemicals and Fertilizers, India chaired a meeting on implications of Poisons Act (1919) in chemical industry.  

One of the issues that brought up in this meeting is the handling of acids and poisons. Currently, the industries that are using a large amount of acid or poisons are under the supervision of local government based on the Poison Act (1919). The supervision has become a challenge when industries increased their use of acids for their end products. Accidents related to processing and storing also become an issue. Experts at the meeting suggest that handling of such chemicals is not sufficient under the current scheme of Poisons Act, and handling/processing of certain acids should even be restricted for industrial use.    

Representatives from the Indian Chemical Council suggest that chemicals of such should be regulated by Indian CMSR, the 5th draft published on August 24, 2020. The Indian CMSR is expected to come into force later this year.   

last update: 2021-04-20

A new chemical risk assessment reporting system also known as Chemical Accident Prevention Management Plan (CAPMP) has been in place since April 1 in South Korea. This new system integrates two existing risk reporting systems - an off-site consequence analysis report and a risk management plan. This reporting system is expected to reduce redundancy and processing time. 

Any facilities managing controlled substances under Chemical Control Act (CCA) should submit to this new plan. Depending on the risks of a substance and its amounts, facilities are categorized into two groups - Group one and two.

Basic information of the substances, risk management plan, and onsite emergency plan are required for all facilities regardless of the facility category. On the other hand, Group one facilities where they have more risks to human and the environment should submit an off-site emergency plan. 

All the submitted reports will be reviewed and inspected by the National Institute of Chemical Safety (NICS). If the reports are not approved, the facilities should re-submit within two months. The reports should be updated every five years.

 

Last update: 2021-04-16

The Ministry of Environment in South Korea plans to include lubricants in the list of products subject to safety checks. 39 consumer products have been listed in K-BPR that will need safety checks. The draft amendment proposed to include lubricants under the 'coatings' category. Once this draft is approved and implemented, lubricants manufacturers and importers should obtain a certificate of effectiveness and efficacy. 

Moreover, the amendment bans the following five substances in lubricants:

  • vinyl chloride;
  • tetrachloroethylene;
  • trichloroethylene;
  • dichloromethane; and
  • ethylene dichloride.

Further, it restricts the following substances: 

  • formaldehyde – 70 milligrams per kilogram (mg/kg) or less;
  • acetaldehyde – 50mg/kg or less;
  • benzene – less than 10mg/kg;
  • bis(2-ethylhexyl)phthalate – 800mg/kg or less;
  • naphthalene – 100mg/kg or less; and
  • nickel – 100mg/kg or less.

 

Last updates: 2021-04-16

Taiwan’s Environmental Protection Administration (EPA) has published the modification of the fee structure for chemical registration on April 7, 2021. In response to the international trend of reducing the use of animal testing, the registration fee of those based on the designated non-animal testing alternatives is adjusted from NTD 50,000 to 37,000. 

After public consultation, the EPA also decides to reduce the application fee for extending the confidentiality period and simplified registration.

Under the TCCSCA, registrants can apply for CBI for items such as information on the registrant, manufacturing/import information, use information and chemical identities. The valid period for CBI is two years for simplified registration and small quantity registration and five years for standard registration.

Below is the updated government fee structure for chemical registration in Taiwan. 

Item of application

Existing Chemical Substance

New Chemical Substance

Phase One Registration

100

 

Standard Registration (106 PECs)

General Case

50,000

50,000

Designated Case

37,000

37,000

Simplified Registration

N/A

20,000

Small Quantity Registration

 

2,000

Extension

Standard Registration

N/A

2,000

Simplified Registration

N/A

1,000

Small Quantity Registration

N/A

1,000

Confidential Business Info.

12,500 per item

12,500 per item

Extension of CBI

10,000 per item

10,000 per item

 

last update: 2021-04-08

Japan is going forward with a global ban on the production, import, and use of Perfluorooctanoic acid (PFOA), its salts, and 2,2,2-Trichloro-1-(2-chlorophenyl)-1-(4-chlorophenyl) ethanol (also known as o,p’-Dicofol), as a part of its commitment announced at the 9th meeting of the Stockholm Convention on (POPs) in 2019.

In February 2021, the Ministry of Economy, Trade and Industry (METI), the Ministry of the Environment (MoE), and the Ministry of Health, Labour and Welfare (MHLW) announced an amendment to the Cabinet Order of the Act on the Evaluation of Chemical Substances and Regulation of their Manufacture, etc. In the proposal, PFOA, its salts, and o,p’-Dicofol will be added to the group of substances regulated as Class 1 Specified Chemical Substances. Class I specified chemical substances under the Chemical Substances Control Law (CSCL) are those substances that Japan has assessed as persistent, highly bioaccumulative, or which have a risk of long-term toxicity to humans.  Under Japan’s Act on the Evaluation of Chemical Substances and Regulation of their Manufacture, etc., manufacture and import of a Class 1 Specified Chemical Substance requires prior authorisation from METI. The use of the regulated substances is only authorised when there are no alternatives available and the use of the substances will not pose a risk to the environment or to human health.

Class 1 Specified Chemical Substances are listed in Article 1 of the Cabinet Order of the Act on the Evaluation of Chemical Substances and Regulation of their Manufacture, etc.

In addition, the following list of products is to be added to Article 7 of the Cabinet Order which prohibits the import of products containing PFOA and its salts.

  • Water-resistant and oil-resistant paper
  • Water-repellent and oil-repellent textiles
  • Cleaning agents
  • Anti-reflection agents used in the manufacture of semiconductors
  • Paints and varnish
  • Water and oil repellent
  • Adhesives and sealing fillers
  • Fire extinguishers, fire-extinguishing agents, and fire-extinguishing foam
  • Toners
  • Water-resistant and oil-resistant clothes
  • Water-repellent floor and oil-repellent floor coverings
  • Floor waxes
  • Photographic paper

The amendment is expected to be finalised by April and come into force in mid-October.

Last update: 2021-04-21

The Australian Industrial Chemicals Introduction Scheme (AICIS) has been implemented since July 1st 2020. Under this Scheme, introducers of chemicals have the obligation to submit an annual declaration. The first deadline of the annual declaration is November 30th, 2021.

All the industrial chemicals placed in Australia, regardless of their categories, are subject to submit an annual declaration to authority. The submission should be carried out via the online submission portal – AICIS Business Services. This annual declaration is a separate requirement from other reporting obligations.

This annual declaration covers industrial chemicals imported or manufactured during the previous registration year. The window for this Annual declaration will open between 1st August 2021 and 30th Nov 2021. The coverage period for this declaration is from 1 July 2020 to 31 August 2021.

The annual declaration should include:

  • your AICIS Business Registration number (starting with ‘NIC’)
  • the introduction categories for the chemicals you imported or manufactured during our registration year
  • a declaration that all of your introductions were authorised under sections 25 to 30 of the Industrial Chemicals Act (2019)

It is possible to view all of your annual declarations in the AICIS Business Services online portal. 

GPC has a legal entity in Australia and we can help you with your Annual declaration submissions. You may contact us at compliance@au.gpcregulatory.com.

 

Last Update: 2021-04-19

On April 8, 2021, the Brazilian Health Regulatory Agency (ANVISA) opened a public consultation on the criteria for conducting Pesticide Residue Studies and for the establishment of Maximum Residue Limits (MRL). The proposal intends to adopt the most recent opinion from the international scenario to the national territory, ensuring a continuous improvement in the quality of pesticide residue’ evaluation. 

The main keys can be summarized as follow: 

  • Increases the number of field trials from 4 to 8, with the possibility that half of the trials come from other countries (decreases calculation uncertainty) 

  • Use of the principle of proportionality to extrapolate the result of studies for the MLR establishment 

  • Turns mandatory the studies’ data be registered on ANVISA’s data bank for inclusion or change into MLR 

  • Define criteria for inclusion on monographs the conformities for MLR and risk assessment 

  • Adopts international homogenization tools  

  • Establish the standard MLR of ≤ 0,01 mg/kg in case of new substances and farming crops 

The interested public can send contributions from April 15, 2021, to June 16, 2021, using this form

Further information is available on ANVISA’s webpage.  

Last update: 2021-04-03

Colombia incorporated GHS guidelines in 2018 based on the Decreto 1.496/2018. The regulation provides guidance for ministries to implement the standard in each sector. In 2021, the Ministry of Labor is the first sector to adopt GHS under Resolución 0773/2021

Colombia government’s attitude toward GHS implementation has been vague until now. This first adaptation can be seen as a confirmation of the country’s adaptation of GHS at the sector’s level.  

Almost a year after the public consultation, the Ministry of Labor had agreed on the following aspects of GHS implementation:

  • GHS 6th version (2015) adoption
  • Follow the European CLP for labeling size
  • SDS and label mandatory in Spanish
  • Organizations shall keep and personal chemical inventory updated
  • Chemicals’ labels must have a 27/7 emergency toll-free contact

The adaptation period differs for substances and mixtures. Substances have 24 months transitional period, while mixtures count 36 months.

Other ministries are still waiting to countersign the guidelines including Ministries of Health, Ministry of Agriculture and Ministry of Transport.

Colombia is one of the latest countries in South America to adopt the GHS standard. Despite its late adoption, Colombia is also advancing its national policy on chemical safety and management. In February 2021, Colombia has carried out public consultation on the comprehensive management of industrial chemicals. Colombia’s chemical policy is expected to be forwarded by the recent adoption of chemical regulation in Chile, a close neighbor, and OECD member. 

Late Update: 2021-04-30

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