GPC Newsletter Aug-2020

The non-confidential portion of EPA’s Toxic Substances Control Act Chemical Substance Inventory (TSCA Inventory) is updated approximately every six months. IThe June 2020 update of the Inventory contains 86,405 chemicals of which 41,587 are active. Next update on the TSCA inventory would be early 2021.

In case of import, UFI can be used in the communication with a non-EU supplier. The following way can be considered to work around possible communication problems (e.g. if the non EU supplier intends to protect the confidentiality of the mixture information).

The non–EU supplier has a legal entity based in the EU (or a contractual agreement with an EU-based legal entity), which creates a UFI and makes a submission voluntarily 33 to the Member States where the EU importer intends to place the mixture on the market. The non-EU supplier informs their customer (the EU-importer, directly or via the EU-based legal entity) about this UFI and confirms that the submission is done. Subsequently, the EU importer, who is the actual duty holder, makes their own submission with a reference to this UFI in relation to the compositional information. The importer could therefore make a submission for a mixture containing 100% of the MiM supplied by the non-EU supplier. This option could be useful also when the EU importer uses the mixture to formulate another mixture, and the non-EU supplier wants to protect the confidentiality of the information on the mixture they supply to the EU importer. The obligation to place UFI on the label lies with the EU importer. It is possible for the non-EU supplier to already label their product with the correct UFI before supplying it to the EU importer.

The EU importer and non-EU supplier are strongly recommended to enter into a contractual agreement to cover the details of the submission approach chosen. It should be kept in mind that the EU importer remains in any case the duty holder and therefore responsible in front of the enforcement authorities. Furthermore, the EU importer remains responsible for the fulfilment of other obligations under CLP (e.g. classification of the mixture).

The nomination period for the Russian Inventory is formally closed now. During this nomination period, the GPC group has helped 20+ companies to nominate 350+ substances. The Russian inventory, which is expected to be published by the end of 2020, will be forwarded to the Eurasian Economic Commission to form a common Eurasian substance Register.   

GPC Group summarizes three scenarios for companies that exporting to Russia:

1. For the companies that have nominated to the Russian inventory, the next step will be the pre-registration and registration of substances in accordance with the TR 041. For now, no official information regarding per-registration and registration is available. 

1. For those companies that did not nominate to the Russian inventory but have been exporting chemicals to the Russian market before 2nd June 2021 (enforcement of TR 041), there is an “exceptional” procedure. A substance that is not present in the Russian Inventory will be considered as “new” for the Russian market. To place that substance laboratory expertise and extensive documentation is expected to be required. The “exceptional” procedure allows a simplified nomination procedure for substances that have not been nominated to the Russian Inventory, but for which a proof can be provided that they have been circulating on the Russian market before the TR 041 enforcement (2nd June 2021).  

1. The companies that have not nominated their substances to the Russian inventory and have not been exporting them to Russia before will be required to nominate their substance to the inventory in accordance with the TR 041. This implies that their substances will be considered “new” for the market and have to be nominated to the inventory before registration. To nominate “new” substances to the Inventory will require laboratory expertise and extensive documentation. All the details on documentation are expected to be announced at the beginning of the next year 2021.   

GPC will continue to keep you updated on the news regarding the Russian inventory and TR 041.

Ministry of Agriculture and Forestry has announced a new draft regulation regarding pesticides on food of plant or animal origin, adapted from European regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC.

The draft is in Turkish language and consists of 4 parts, spread onto 5 pages, including a temporary article on the transition period for the application of the regulation. In addition to the regulation, there will be 5 annexes on the proper application of the regulation.

The draft is proposed to be finalized after 31st August 2020, and published by September 10th, 2020. It is then expected that the regulation will be adopted at the end of September and the provisions enter into force by the end of this year, 31st December 2020.

Source: Ministry of Agriculture and Forestry

What is CMSR?

India released the fourth draft of the Chemical (Management and Safety) Rules (CMSR) on March 16, 2020. The CMSR will regulate Substances, Substances in Mixture, Substance in Articles and Intermediates that are manufactured, imported, or placed in the Indian Territory. The legal basis of the CMSR is section 3, 6, and 25 of Environmental Protection Act (1986) ; Further enactment of CMSR will result in suspension of two existing rules - Manufacture, Storage and Import of Hazardous Chemical Rules (1989) and Chemical Accidents (Emergency Planning, Preparedness and Response) Rules (1996). The CMSR is expected to come into force in 2020-2021. Indian manufacturers, importers and authorized representation (AR – acting on behalf of a foreign manufacturer) with an Indian legal entity, can comply with the CMSR..

How to Comply?

Notification

Notification is required for all substances that are in quantity above 1 TPA. Data Requirement for Notification: Submit Chemical information, Spectral data, Hazard Classification, Uses details, details of DU, Tonnage band, Storage capacity and SDS. A certificate of Notification along with Notification number will be issued once the notified substance is evaluated for its completeness by the Chemical Regulatory Division. Annual reporting is required for all Notified substances, to be submitted on 30th of Jan each year, and any change in tonnage band or other notified information will required to be promptly updated and may attract tonnage band change fee.  All New Chemical Substances must be notified at least 90 days prior to the date they are placed in Indian territory.

Registration

Only identified substances meeting criteria of “Substances To Be Registered” in Schedule VI of the CMSR and with the tonnage exceeding 1 TPA need to be registered. Currently, there are 37 Substances in Schedule VI and this list will be updated on regular basis. Registration should be carried out within 18 months after a substance is included in Schedule VI. Technical dossiers should be submitted while registering substance. For substance with a tonnage band more than 10 TPA, a Chemical Safety Assessment is also required to be submitted along with Technical dossier. Registration fee will depend on tonnage band and company size. Joint submission is a recommended option. The Intermediates with the tonnage band less than 1000 TPA should be registered with only the physical and chemical properties in the Technical Dossiers. Whereas Intermediates with the tonnage band above 1000 TPA should register with full information in the Technical Dossier along the Chemical Safety Report. Priority Substances in Article with the tonnage that exceeding 1 TPA will also need to register.

Annual Reporting

An annual report applies to all notified existing and new substances. The report should contain the quantity of substance place in India Territory in the previous calendar year and changes of information submitted at the time of notification. This should be done before the 30th of January of each calendar year.

Foreign Manufacturer and Authorized Representative

Foreign Manufacturers of substance, substance in mixture and priority substance in article should appoint an Authorized Representative that has an Indian legal entity to comply with the CMSR.

Actions for Manufacturers, Importers and Downstream Users

• Set up a regulatory team 
• Prepare an Inventory of substances being handled
• Identify the quantity placed in India
• Initiate communication with downstream users -
• Update SDS in accordance with GHS Rev. 8
• Stay updated on the CMSR
• Internal training on the CMSR
• Follow up on the Substance lists (Substances to be registered (Schedule VI), Priority Substance (Schedule II) and Hazardous Substance (Schedule X, XI, XII)) with us on gpcgateway.com  

On April 29, 2020, China's Ministry of Ecology and Environment (MEE) published the Measures on Environmental Management Registration of New Chemical Substances (MEE Order 12). The amendment will come into force on January 1, 2021 and replace the current MEP Order 7. The updated text focuses on the management of persistent (P), bioaccumulative (B), and toxic (T) substances, including defining scenarios in which substances meeting the PBT criteria will not be approved. MEE Order 12 introduces Simplified Registration as well as post-registration management. 

Depending on annual tonnage, new chemical substances will be subject to three types of registrations: Regular Registration, Simplified Registration, and Filing. 

New substances with annual volumes between 1 and 10 tons will be subject to the Simplified Registrations under MEE Order 12. Registrants should provide following information: (1) the application form; (2) physicochemical properties, and ecotoxicological study reports or materials regarding persistency, bioaccumulation, and aquatic environmental toxicity; and (3) a commitment letter on implementation or transmission of environmental risk control measures.

For New Substances of more than 10 tons, registrants should submit Regular Registration, including following information: (1) the application form; (2) physicochemical, toxicological and ecotoxicological test reports or materials; (3) an environmental risk assessment report; and (4) a commitment letter on implementation or transmission of environmental risk control measures.

The first-activity report is required for both Simplified Registrations and Regular Registrations and should be submitted within 60 days since the first manufacture or the first transfer to customers after import.

CBI Protection: CBI protection for substances currently in the IECSC will be abolished by 31 December 2025. The maximum time applicable for CBI protection of new substances added to the inventory of existing chemicals in China (IECSC) will be 5 years.

For further details, please click on the link to the official announcement 

www.mee.gov.cn/xxgk2018/xxgk/xxgk06/202006/t20200603_782493.html

For further information, kindly contact us on compliance@gpcregulatory.com

South Korea’s Occupational Safety and Health Act (often called KOSHA) amendment on material safety data sheets (MSDSs) takes into force on 16 January 2021. Chemical manufacturers and importers shall prepare and submit an MSDS to the Ministry of Employment and Labor (MoEL). Besides, it becomes mandatory for a company to get a non-disclosure approval from the MoEL in the case where a company is reluctant to disclose certain chemical information in an MSDS. The following section outlines major changes in the amendment, affected stakeholders and its implications.

Major Updates

The KOSHA amendment implies changes in obligations and processes to prepare and submit an MSDS, which are summarized into four sections as follows: an MSDS preparation and submission; an MSDS provision; chemical information non-disclosure approval and only representative (OR) appointment.   

An MSDS preparation and submission

Chemical manufacturers and importers shall submit an MSDS for GHS classified chemicals or compounds (chemicals subject to MSDS) to the MoEL before manufacture and import. For non-GHS classified chemicals, they shall either include the name and content of chemicals in an MSDS or submit a confirmation document proving that chemicals are not GHS classified. In case of non-compliance, a penalty of not more than 5 million KRW (equivalent to 5,000 USD) will be charged.

Chemical manufacturers and importers are entitled to a grace period for an MSDS preparation and submission for a product that is already distributed on the market. The grace periods vary depending on the annual manufacture and import volume of the product.  

The below table shows a summary of the comparison before and after the amendment.  

An MSDS provision

Chemical suppliers shall provide an MSDS to their chemical recipients. Changes in the submitted MSDS shall be reported to the recipients accordingly. For those who failed to provide an MSDS to their chemical recipients, a penalty of not more than 5 million KRW (equivalent to 5,000 USD) will be charged. In case of negligence in reporting the changes of the MSDS, a penalty of not more than 300 million KRW (equivalent to 3,000 USD) will be charged.

Chemical information non-disclosure approval

Where a company does not want to reveal certain chemical information such as names and contents in an MSDS due to confidentiality reason, a pre-approval from the MoEL is required. For communication of the hazards and risks of such substances in the supply chain, alternative names for such substances and their composition shall be provided when submitting a pre-approval application. Once approved, it is valid for five years, which shall be renewed a month before the current approval period expires.

The authority shall inform the result of whether or not to approve an application within a month after the receipt of the application. Chemical substances used for R&D purpose have shortened and simplified process for the approval, for instance, the result shall be informed within two weeks of the application. A company objects to the authority’s decision can appeal within a month from the receipt of the decision, and then the appeal result shall be informed within 20 days.

Only Representative (OR) appointment

If overseas chemical manufacturers are reluctant to provide their chemical information to importers in South Korea, they can appoint an only representative (OR). On behalf of an overseas manufacturer, an OR submits an MSDS that includes chemical composition, its hazards, and risks; chemical information that is not GHS classified; and applies for MSDS non-disclosure approval.

Key affected stakeholders and implications

The KOSHA amendment on MSDS as outlined above will be enforced from 16 January 2021.

Chemical manufacturers and importers are obliged to submit MSDSs to the Ministry of Employment and Labor (MoEL). When there are changes in MSDSs, they shall revise and share them with their chemical buyers.

The deadlines for an MSDS submission depend on the volume of the chemicals they manufacture and import, for instance,

• the volume over 1,000 tons per year shall submit their MSDSs to MoEL by 16 January 2022
• the volume above 100 tons below 1,000 tons per year by 16 January 2023
• the volume above 10 tons below 100 tons per year by 16 January 2024
• the volume above 1 ton below 10 tons per year by 16 January 2025
• the volume less than 1 ton per year, by 16 January 2026 respectively

When companies are reluctant to disclose chemical information due to confidential reasons, non-disclosure approval from MoEL is required. They need to prepare technical information such as alternative names of the substances. Such companies shall be aware that substances having high risks and hazards might not be approved for non-disclosure approval.

Overseas manufacturers and exporters can appoint an OR to fulfil obligations under the KOSHA.

Relevant Services provided by GPCKOREA

• Regulatory compliance support
• Technical assistance for an MSDS preparation
• Only Representative to fulfil various obligations under KOSHA

Updated: 17 July 2020

The Chemical Product Safety Act, often known as K-BPR, enforced on 1st January 2019, regulates safety management of consumer products and biocidal products. The amendment of this Act was approved by South Korea’s Parliament and Cabinet on 4 March 2020. It will enter into force from 1stJanuary 2021. Key summaries of the amendment are (* refers to the amendment that will come into force immediately from the approval date of the amendment): 

1. Non-Korean manufacturers can appoint an Only Representative (OR) to register biocidal active substances,
2. The defined biocidal active substances can be manufactured and imported during the transition periods*,
3. Data submission for biocidal products approval can be exempted when the data are already submitted under K-REACH*,
4. The Ministry of Environment discloses information on the notified and approved consumer products including the product name, manufacturer or importer details and the main components of the product etc.,
5. Measures to reduce vertebrate animal testing

For further information, please feel free to contact us compliance@gpcregulatory.com 

On March 11, 2019, Taiwan’s EPA published the amended regulation on New and Existing Chemical Substances, specifying Standard Registration for 106 existing chemical substances. From 1 January 2020, manufacturers or importers who manufacture or import any Existing Chemical Substance in an annual amount of 100 kilograms or more, should apply for the Phase One Registration within 6 months from the date of manufacture/import. The amendment also includes a requirement of annual reporting. Annual reporting requires importers/manufacturers to report the volume of manufacture or importation of registered new and existing substances from the previous calendar year between 1st April and 30th September. Information for annual reporting include: 

• Substance name
• CAS No.
• Registration number for each substance
• Volume in the previous year
• Importer or manufacturer

Non-Taiwanese manufacturers for business reasons that want to maintain the confidentiality of its product compositions and do not want to share with their Taiwanese clients (importers), may ask the importers to nominate a Third Party Representative (TPR) who can prepare and submit the annual reporting without having to revel the composition details of the product. Reporting is required to be submitted separately for each importer. GPC Regulatory – provides these services and you may contact us on compliance@gpcregulatory.com for the TPR services.

In addition, GPC Regulatory can support you to comply with various aspects of TCCSCA such as Phase-One Registration(s), Priority Existing Chemicals (PEC) registration(s) and new substance registration(s) and submitting them as a your TPR.