GPC Newsletter Jan-2021

Hello!

We welcome you to our first newsletter in 2021. In this month’s newsletter, you’ll find the latest regulatory updates that we have selected and prepared for you. We want this newsletter to be valuable for you and your company, please share your feedback and suggestions to help us to improve.

Follow us on LinkedIn and visit our website to receive the latest webinar event information and news.

Best wishes,
GPC Newsletter Team



Regulatory News

ECHA has added two new substances to the Candidate List of substances of very high concern (SVHCs) for authorization on 19 January 2021. Now the list contains 211 substances in total.

These two substances were added to the Candidate List as they are toxic for reproduction and hence may adversely affect fertility and cause developmental toxicity in offspring. Both the substances are used in products like inks or toners and also used to produce plastics and rubber tires.

#

Substance name

EC number

CAS number

Reason for inclusion

1

Bis(2-(2-methoxyethoxy) ethyl)ether

205-594-7

143-24-8

Toxic for reproduction
(Article 57 (c)) 

2

Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety

-

-

Toxic for reproduction
(Article 57 (c)) 

ECHA suggests companies notify ECHA under the Waste Framework Directive (SCIP) if their products contain substances of very high concern.

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

 

Update: 2021-01-19

The European Commission announced the EU Chemicals Strategy for Sustainability on 14th October 2020, as a key commitment policy to the European Green Deal. The ambition of the European Green Deal is to ensure climate neutrality and circular economy by 2050. The chemical strategy is considered one of the most important parts of the Deal, since it ensures safer environment and health. The strategy is anticipated to have a very large impact on chemical industries related to the EU market.

The European Commission recognises the importance of chemicals for better and higher living standards, however given the hazardous properties of chemicals it has been considered of importance to implement further actions in making chemicals safer and more sustainable. The Strategy’s goals can be divided into two groups:

The goals for increased protection of health and environment, which among others include:

- Phasing out harmful substances form consumer products

- Substituting substances of concern in all products,

- Ensure information access on chemical content and its safe use for producers and consumers.

 

Goals that boost innovation for safer and more sustainable chemicals, which among others include:

  • A financial support in ensuring safe and sustainable-by-design chemicals,
  • increase enforcement of EU regulations,
  • Simplification and accessibility of EU legal framework by the ‘One substance one assessment' process for the risk and hazard assessment of chemicals
  • playing a leading role globally by championing and promoting high standards and not exporting chemicals banned in the EU.

At the Chemical Watch conference “Global Chemicals Management towards 2030 and beyond”, the ECHA Executive Director Bjorn Hansen described the Chemical Strategy as “welcomed by ECHA”. Hansen states that the strategy is anticipated to eliminate regulatory information barriers and enhance the reuse of data collected under different regulations. Furthermore, a more harmonized chemical’s database is expected to greatly facilitate the research processes for scientists in Europe. According to Hansen the Chemical Strategy 2030 is intended to review, revise, and clearly articulate the existing policies and enhance efficiency within the chemical regulatory framework.

The ambitious chemical strategy might lead to a “reopening” of the EU REACH. Some central European countries have expressed their worry regarding the potential “reopening”. Their main concern is that excessive amendments to REACH regulation, in relation to the Chemical Strategy, may lead to pressure on the industries. There are more than 50 action plans laid out to be taken before 2024, as a part of the implementation of the strategy. An introduction of new hazard classes for the CLP Regulation is, for example, expected to be implemented already this year (2021).

The final conclusions regarding the strategy’s implementation are, however, expected to be clarified in March at the next Environment Council meeting. The general support of the strategy by the member states nevertheless predicts a general smooth implementation of the strategy.

 

Update: 2021-01-29

 

 

According to a statement released by ECHA on January 11, 80% of all EU-REACH registrations held in the UK have been or are in the process of being transferred back into the EU.

The remaining 20%, for which the transfer process had not been initiated before 31st December 2020, have now become invalid. As a consequence, ECHA warns, holders of non-transferred registrations are not allowed to place the corresponding substances on the EU market anymore.

As to the registrations that are currently being transferred, ECHA calls upon all actors concerned both in the UK and the EU to complete the transfer process by 31st March 2021. All registrations that have not been transferred will become invalid past this date.

Source: ECHA

Update: 2021-01-12

Following the end of the Brexit transition period on 1st January 2021, the UK REACH Regulation is now in force. UK REACH, which has been described as mirroring its EU counterpart, applies instead of EU REACH in respect of Great Britain (England, Wales and Scotland.) The main consequence is that EU REACH registrations issued by ECHA will no longer be valid in the UK. In order to be placed on the GB market, a substance will thus need to be registered under UK REACH.

With the aim of assisting the many exporters likely to be affected by the repeal of EU REACH in the Great Britain, UK REACH provides for comprehensive transitional arrangements. Such arrangements concern both EU and non-EU based exporters dealing with substances already registered under EU REACH and wishing to maintain access to the UK.

UK REACH may apply to you if your business falls under one of these two situations: 

You are a non-GB-based manufacturer exporting chemical substances registered under EU REACH to the UK, and who wishes to maintain access to the GB market. You can: 

  • Let your GB-based downstream user/distributor/formulator file a Downstream User Import Notification (DUIN) by 27 October 2021, followed by full registration of your substance within 2, 4 or 6 years depending on tonnage band and hazard profile, or
  • Appoint a GB-based OR to carry out the DUIN followed by full registration of the substance under UK REACH.

You are a non-GB-based manufacturer who wishes to export chemical substances that are not registered under EU REACH to the UK. You must:

  • Complete full registration of your substance immediately. You can appoint a GB-based OR to carry out that requirement on your behalf.

 

Global Product Compliance has a GB-based OR facility, ‘GPC UK’, ready to assist its existing and future clients in complying with UK REACH.

Update: 2021-01-22

Russian Ministry of Industry and Trade (Minpromtorg) has now published the finalized version of the inventory of chemical substances. The finalized version contains +80.000 substances notified to the Minpromtorg from December 2019 to August 2020. The inventory is published on the GISP.ru portal and is available for public review. In this online portal, it is possible to search substances via CAS number, EC number, or through IUPAC names and synonyms.

The Russian inventory and the national chemical inventories of other EAEU member states are expected to form one common EAEU inventory. A tentative date for the publication of national parts of the EAEU inventory is October 2021.  

Furthermore, a proposal has been sent to the EAEU Commission and circulated among member countries. The proposal aims to postpone the implementation date of TR 041 from 2nd June 2021 to 30th November 2022. So far, no clear decision has been announced. GPC will keep you and your company updated on any upcoming news regarding the TR 041.

Update: 2021-01-28


The registration phase for Turkey REACH has kick-started by 1st of January 2021 as the deadline for pre-registration was passed. During the pre-registration phase, GPC has pre-registered around 3200 substances to secure business of our clients for the upcoming years in Turkey.

According to the latest updates from the ministry, the pre-registration will be possible until the end of the registration phase, 2023-12-31 but it is crucial to submit pre-registrations as soon as possible to benefit from joint registration and actively participate in SIEFs.

 If you haven’t pre-registered your substances, you can send the list of your substances to us and as your seamless global regulatory extension, GPC will pre-register your substances as well as represent your company in the SIEFs. Please keep in mind that it is important to contact us as soon as possible to be able to benefit from the advantages of joint registration.

Update: 2021-01-01

 

On January 11, 2021, a stakeholder consultation meeting was organized by Additional Secretary (Chem) to discuss BIS standards of 12 chemicals. Nine of the twelve standards under consideration are concluded to be made mandatory. The 12 BIS standards that are being considered are:

  1. Carbon Black IS 17440:2020 (HS Code 2803 0000)
  2. Calcined Alumina IS 17441:2020 (HS Code2818 2010)
  3. Anhydrous Ammonia IS 662:2020 (HS Code 2814 1000)
  4. 1,3 Phenylenediamine IS 17450:2020 (HS Code 29215120)
  5. Pearlescent Pigment (HS Code 3206 1110) coated with Titanium dioxide more than 80%. The BIS standard of Titanium Dioxide is available under IS 411:2020 (HS Code 28230010)
  6. Lauric Acid IS 10931:1984 (HS Code 29159090)
  7. Acid Oil IS 12029:1986 (HS Code 38231900)
  8. Palm Fatty Acids IS 12067:1987 (HS Code 38231900)
  9. Rice Bran Fatty Acids IS 12068:1987 (HS Code 38231900)
  10. Coconut Fatty Acids IS 12069:1987 (HS Code 38231900)
  11. Rubber seed Fatty Acids IS 12124:1987 (HS Code 38231900)
  12. Hydrogenated Rice Bran Fatty Acids IS 12361: 1988 (HS Code 38231900)

Summary of individual Standards is as follows:

Carbon Black: After consultation with industry members, Additional Secretary (Chem) required the industry representatives to clearly specify what amendments are needed to be made in BIS standards (IS 17440:2020). He also stressed that Industry should not make a general request that BIS standards have to directly adapt ASTM standards and it is for BIS to decide. A six-week timeline was given to the industry for the same.

Calcined Alumina: AS (Chem) advised opportunities to be provided to stakeholders who have given written comments to BIS for discussion in Technical committees irrespective of if they are members or not of the technical committee. It proposed to take a final position within a month to consider making standard as mandatory.

Anhydrous Ammonia: No inputs were provided by the fertilizer or refrigeration industry, its therefore concluded that discuss this item in the next meeting with representative from Fertilizer and Refrigeration industry.

1,3 Phenylenediamine: After deliberation, the committee decided to make BIS standard mandatory for 1,3 Phenylenediamine.

Titanium Dioxide: No representative from Paint association attended the meeting. AS(Chem) stated that Standard of Titanium dioxide should be made mandatory, keeping in view the human health and environment consideration, and considerable imports and production within India (Titanium dioxide, the main component of pearlescent pigment (higher than 80%)).

Pearlescent Pigment: No representative from Paint association attended the meeting. AS (Chem) directed that BIS can also explore standard for Pearlescent Pigment.

Fatty Acids: Lauric Acid, Acid Oil, Palm Fatty Acids, Rice Bran Fatty Acids, Coconut Fatty Acids, Rubber seed Fatty Acids, Hydrogenated Rice Bran Fatty Acids: The standards for these fatty acids, a chemical commonly used in manufacturing soaps and other similar industries, are old and have been reaffirmed by BIS. The committee has decided to make standards of the above-mentioned Fatty Acid as mandatory.

Source: Minutes of the Stakeholder Consultation Meeting, the Chairmanship of Additional Secretary (Chem), Department of Chemicals & Petrochemicals, India

Update: 2021-01-21

 

On 21 Dec. 2020, China MEE announced that the second batch of 238 substances have fulfilled the requirements for IECSC supplementation and will be managed as existing chemical substances. 

On 17 November 2020, China MEE released a public consultation on 245 substances that have applied for IECSC supplementation. Among them, 238 substances have passed the review and have been added to the IECSC. The rest 7 substances are still new chemical substances and will be managed as new substances. 

MEE also reminds enterprises that substances not listed in IECSC will be regarded as new substances and have to be registered as per the new regulation MEE ORDER 12 effective from January 2021. 

Update: 2021-01-19

On the 24 December 2020, China’s Ministry of Ecology and Environment (MEE) released the final versions of technical risk assessment guidelines. These guidelines will guide and regulate risk assessment activities and assisting the implementation of MEE Order No.12.

The recently published guidelines are:

  • Environmental and Health Hazard Assessment (trail) – Appendix 1

This guideline uses GB 30000 series standards and GB/T 24782 as the main resources in hazardous assessment. It sets down the general principles and requirements for the assessment procedures and contents of chemical substances.

  • Environmental and Health Exposure Assessment (trail) – Appendix 2

The main material referred in this guideline is HJ 2035 standard – Technical Guideline on Solid Waste Disposal. This guideline is supposed to be used for risk assessment of environmental and health exposure evaluation.  

  • Environmental and Health Risk Characterization (trail)- Appendix 3

There is no specific standard referred to in this guideline. However, this guideline will rely on MEE Order No.12, Guidelines for MEE Order No.12, and the Technical Framework Guidelines on the Risk Assessment of Chemical Substance which are the common resources for the three guidelines. Specifically, it includes the main principles, procedures, and technical points for environmental and health risk characterization of chemical substances.

All of the three guidelines mentioned above came into force from the day they were enacted. However, as the term ‘trail’ in the name of the guidance indicated, these guidelines can be modified depending on the actual situation of implementation.  

 

Download Environmental and Health Hazard Assessment (trail) – Appendix 1 (In Mandarin)

Download Environmental and Health Exposure Assessment (trail) – Appendix 2 (In Mandarin)

Download Environmental and Health Risk Characterization (trail)- Appendix 3 (In Mandarin)

Update: 2021-01-20

South Korea added three substances in the 741 existing biocidal substance list therefore, the total number of biocidal chemicals in the existing list becomes 744 entries. It includes:

  • Chlorine dioxide generated from sodium chlorite by oxidation (CAS 10049-04-4)
  • Active chlorine released from sodium chlorosulfamate (CAS 13637-90-6)
  • Active chlorine generated from sodium chloride by electrolysis

Each substance has limited use, for instance, the first substance (CAS 10049-04-4) can only be used as a disinfectant; The second substance as preservatives for materials and equipment; and the third substance as a disinfectant. Once They all have extended full registration deadline of 2029 December 31.

In the same announcement, the MoE updated full registration deadline for 34 substances in the existing 741 biocidal list and the allowed uses.

Affected stakeholders and implications

Manufacturer and importer of the biocidal substances in the existing list shall submit an Approval Plan to benefit from the extended full registration deadline. In the case of a non-Korean manufacturer, one can appoint an Only Representative to comply with K-BPR obligations.

 

Update: 2021-1-13

The recent MSDS amendment in South Korea was enforced on 16 January 2021. This amendment requires chemical manufacturers and importers to deliver and submit an MSDS to the competent authority (Korean Occupational Safety and Health Agency, KOSHA) via the IT system. Besides, an MSDS has to be submitted before the manufacture and import; and the due date for submission varies depending on the tonnage band. At the earliest, it should be done by 2022 January 16 for those who manufacture and import more than 1000 tpa and the latest due date will be 2026 for less than 1 tpa tonnage band.

The second important aspect of the MSDS amendment is that non-disclosure of Confidential Business Information in an MSDS shall be approved in advance. Substance information that considers as confidential for instance, substance name and contents shall not be left blank but should be written with alternative names or contents. Last but not the least, according to the amended MSDS regulation, non-Korean manufacturers should appoint an Only Representative to fulfill their responsibility of submitting an MSDS.

Affected stakeholders and implications

Manufacturer and importer of chemical substances should submit an MSDS to the KOSHA via the IT system. As a non-Korean manufacturer, you can appoint an Only Representative to comply with regulatory obligations. GPC Korea provides services including drafting an MSDS and submitting the MSDS to the authority as an OR. GPC Korea will keep your MSDS up-to-date according to the recent regulatory requirements and translate it into a local language. 

 

Update: 2021-01-14

Japan’s Ministry of Environment (MoE) in 2021 has published the schedule for companies to notify new chemical substances manufactured or imported in volumes of less than 10 tonnes/year, or apply for the small volume chemical permits under the Chemical Substances Control Law (CSCL).

For receiving the confirmation of manufacturing or importing a small amount of chemicals substances from the Government of Japan, one can apply through following methods under the given dates;

  1. Online electronic submission.
  2. Optical disc mailing.
  3. By E-mail.

Sr. No.

Application dates

Notification deadline

1.

13–22 January

For documents: 13–20 January

26 March

2.

1–9 April

No postal applications

20 May

3.

6–14 May 

No postal applications

20 June

4.

1–10 June

For documents: 1–4 June

15 July

5.

1–9 July

No postal applications

10 August

6.

1–6 September

For documents: 1–10 September

15 October

7.

1–8 October

No postal applications

10 November

8.

1–10 November

No postal applications

10 December

9.

1–10 December

For documents: 1–6 December

15 January

The Applicant willing to manufacture or import the chemicals must include all the relevant details about Company Name, Addresses, Notifier or Responsible Person with the amount of Volume and use of chemicals to be exported. The online electronic submission can be favorable in the time of Covid-19, which can be done by uploading the applications to the Ministry of Economy, Trade and Industry (METI).

The Ministry of Health, Labour and Welfare (MHLW), MoE and METI are jointly responsible for processing the applications.

The penalty for non-compliance is prison of up to one year or a maximum fine of 50M Japanese yen.

Click here to see more Information (In Japanese)

Update: 2021-01-28

 

On January 4th, 2021, the Brazilian National Health Surveillance Agency (ANVISA) addendum, concerning the active substance Glyphosate (G01), entered into force. The resolution RDC 441/2020 applies to all technical and formulated products registered or to be registered in Brazil. The resolution defines:

  • The inclusion of formaldehyde (1g/kg) among contaminants of toxicological importance
  • Addition of Acceptable Operator Exposure Level (AOEL) of 0.1 mg/kg of body weight per day, and Acute Reference Dose (ArfD) of 0.5 mg/kg of body weight
  • Change in Acceptable Daily Intake (ADI) to 0.5 mg/kg body weight
  • The Glyphosate residues definition now applies for compliance with Maximum Residue Limit, and dietary risk assessment (sum of Glyphosate and AMPA), expressed as Glyphosate
  • Prohibition of polyoxyethylene amine (POEA) above 20%

In addition to the changes, the resolution determines that package inserts and labels shall be revisited to include information on the use of drift reduction technology in the following cases:

  • It is mandatory to use 50% drift reduction technology for doses above 1.800g/ha in coastal, stationary, semi-stationary, and tractor applications; and
  • obligation to use 50% drift reduction technology and five-meter boundary for doses above 3,700g/ha in the same circumstances.

Companies have 180 days from the publication of the resolution to update package inserts and labels.

Manufacturers and users must pay special attention to the regulation to ensure compliance and avoid unnecessary exposure.

Source: WTO Notification 

Update: 2021-01-12

In 2020 Colombia became the third Latin American country to join the OECD. As a membership requirement, the country has to develop a chemicals management system, including chemical regulation. The chemical regulation draft named integral management of chemical substances for industrial use was posted in December 2020 and notified the World Trade Organization (WTO) on January 4, 2021. The new proposal is open for public participation until February 26, 2021. 

This draft is now under review from industries in Colombia, and the major concern is mostly related to registry requirements and hazard-based provision. Colombia's National Association of Industries (ANDI), for example, expressed their concerns over the chemical regulation presented in July 2020, specifically for the obligation to register the industrial chemicals.

Colombia's draft proposes establishing a national inventory. The current draft proposes that all substances manufactured or imported to Colombia which present at least one GHS hazard and exceed 100 kg/year would need to require information such as: 

  • manufacturer/importer information; 
  • annual production or import volume of chemical; 
  • chemical substance identification (if applicable, CAS number); 
  • identified uses. 

The latest draft scopes those substances identified and classified by the GHS, excepted those controlled by existing regulation, mercury and composed, natural substances, polymers, substances in customs transit, non-isolated intermediaries, and samples without commercial value.

In addition to the Inventory, a registry is foreseen as complementary data for those substances identified as priorities. The criteria for priority substances will be defined on further regulations. Those Importers and manufacturers that deal with 100 Kg of substance or more will have to conduct the environmental and health risk assessment and propose risk reduction and management plans. 

Colombia adopted the GHS 6th Edition in 2018, and it might be the first comprehensive chemicals management framework adopted in Latin America, ahead of Chile and Mexico. The draft is currently published for public consultation, and this might be the last step before the bill is introduced.

 

Update: 2021-01-29

 

 

When Israel joined the OECD in 2010, the country planned to establish a national mechanism for registering chemicals. There are various regulations in Israel that regulate the practice of chemicals, aspects of import, production, occupation, use, maintenance, transportation, and so on. However, the existing regulation is decentralized and usually does not include a systematic assessment of the chemicals and their effects on the public and the environment in Israel.

Last year, Israel proposed a new draft law, the “Industrial Chemicals Registering Law, no 5781-2020”.  This law was notified to the World Trade Organization on January 6th, 2021. Comments can be submitted within 60 days of notification.

The mechanism proposed in the draft law is based on the following components:

  • Establishment of existing chemical inventories - which will constitute a minimal information base in relation to chemicals manufactured or imported in Israel, and will include the properties of the chemical, quantities and uses for which it is intended (these predict the routes of exposure of man and the environment to him).
  • Risk assessment from chemicals - is performed for selected chemicals according to criteria that relate to the risk assessment and the assessment of potential exposure to them. Additional criteria proposed in this memorandum are the existence of assessments and recommendations for the regulation of chemicals elsewhere in the world.
  • Regulation of risk management from the chemical - creating limits to reduce the risk from exposure to the chemical - from the production process through the daily use of the final product to its disposal at the end of its life. It should be noted that the manner of regulation among the existing mechanisms in the world is not uniform and varies according to the powers of the mechanisms.

As part of the formulation of the bill, a comprehensive review of existing mechanisms in the world was conducted, a comprehensive consultation process took place with relevant regulators, with industry stakeholders and with environmental organizations and academic bodies involved in the subject.

Similar to the Toxic Substance Control Act (TSCA) of the US, there will be two sets of chemicals: existing and new. For new chemicals that are manufactured or imported into Israel, the Israeli entity that will be responsible for handling said chemical will have to register it 30 days prior to its manufacture or importation. The threshold for exemption from registration is 10 tonnes per year.

Israel’s Ministry of Environment Protection expects the country’s draft law to be approved by the end of 2021. With this timeline, the proposed effective date of the law is March 1, 2023, and if enacted, manufacturers and importers will have until September 1, 2024 to submit the required data and register the substances.

update: 2021-01-31

Top