GPC Newsletter May-2020

According to Taiwan’s Toxic and Concerned Chemical Substance Control Act (TCCSCA), new and existing substances must be registered in Taiwan. The first batch of 106 PECs was published on 11 March 2019. Taiwan’s EPA published the draft of Guidance for Standard Registration of Designated Chemical Substances by stages in September 2019. After a long waiting, the official guidance for standard registration, Guidance on Existing Chemical Substances Standard Registration (1st version), was released on 9 June 2020. In comparison with the Guidance published in September 2019, the new guidance accepts data from more choices. According to recently published guidance, reports from laboratories of universities in Taiwan are acceptable for data on chemical and physical properties. For toxicological and ecotoxicological information, Taiwan’s EPA accepts reports from laboratories of universities in Taiwan and laboratories with certification of ISO 17025. If animal testing is required for obtaining toxicological and ecotoxicological information, the experiment must form an Institutional Animal Care and Use Committee (IACUC) and follow Animal Protection Law (enforced on 16 December 2018).

According to recently released guidance, a registration number will be issued after registrants submit information (1) to (6) in Appendix 7 (see table below). Taiwan’s EPA reserves the right to ask registrants to provide information on hazard assessment (7) and exposure assessment (8) later.

The recently published Guidance can be seen as an effort from Taiwan’s EPA to facilitate companies to comply with standard registration of 106 PECs. Companies are recommended to set up their regulatory team to fulfil their obligations or contact compliance service providers to learn about their options (e.g. joint registration and benefits of registration via Third Party Representative).

For more information or queries, please write to us at: compliance@gpcregulatory.com

Russia is the only country of the Eurasian Economic Union that is in the process of a national inventory formation.

Since 2019, Russia has opened its inventory for notification of chemical substances present on the Russian market.  Substances that had nominated to the inventory have not been open to the public. On 15 June 2020, the Russian Ministry of Industry and Trade (the responsible institution), has published the so called “Transitional inventory” - listing all the substances that have been nominated to the Inventory. This inventory is now available for public access on the Ministry’s website. We have also included this transitional inventory on the GPC Eurasia page (https://www.gpcgateway.com/) for your convenience. You can search directly on our webpage to know if the substances have been nominated.

Only Russian-based companies are eligible to nominate substances to the inventory. We would like to remind you that the process of the nomination to the Russian inventory is free of charge and does not require extensive documentation – therefore it is highly recommended to nominate to the inventory, in case if you are already importing to Russia or planning to do so. The deadline for the inventory nominations is 1 August 2020.

GPC can help you to complimentary nominate your substances to the Russian Inventory and assist you as your Only Representative (OR).

For more information or queries, please write to us at: compliance@gpcregulatory.com

In the context of the COVID-19 pandemic, European states are encouraged to apply derogations to the normal product authorisation requirements of the Biocidal Products Regulation (BPR) (‘health emergency permits’) to increase and speed up the production of disinfectants. However, some companies appear to be taking advantage of the situation.

20 EU Member States have reported an increase in non-compliant (hand) disinfectants on their markets since March 2020. Such disinfectants can be a health risk rather than keep us safe.

Many of the reported cases are of disinfectants that do not have the required authorisation or permit, or lack hazard labelling. Many had a formulation that cannot be sufficiently effective against viruses – for example, due to insufficient concentrations of active substances with virucidal activity that stops the spread of viruses.

Hence, National enforcement authorities are taking action to protect citizens from the risks of illicit and ineffective products. ECHA is also collecting the national authorities’ feedback on specific difficulties and urgent questions that need to be clarified to support enforcement at a national level. ECHA and the European Anti-Fraud Office (OLAF) decided to share information of mutual interest collected in the context of inquiries related to the COVID-19 crisis. In March 2020, the unit in charge of fighting against forged goods and illicit trade in OLAF has launched an enquiry into illegal trafficking of COVID-19 related products, including disinfectants.

For more information or queries, please write to us at: compliance@gpcregulatory.com

ECHA has announced new obligations for the mixtures being placed into the EU market. For every mixture placed on the market, a new notification i.e., Poison Centre Notification (PCN) will be required to be submitted.

The companies placing mixtures, which may contain classified substances, on the market have to provide information about such mixtures to the relevant national appointed bodies.

This information has to be provided in a harmonized format:

• From 1st January 2021 for mixtures that are used directly or indirectly in consumer uses.
• From 1st January 2021 for mixtures for professional use.
• From 1st January 2024 for mixtures for industrial use.

Recently, ECHA has published the following using tips to avoid mistakes for successful notification of the hazardous substances to Poison Center:

• Use the Validation Assistant – It runs over 120 checks. It checks for missing or inconsistent information and also for quality issues.
• Check Your Legal Entity – Legal entity for your mixture must be the same as the one logged into the portal.
• Update Vs. Initial notification – In this case, if the notification fails, then create an “Initial Submission” and do not submit an “update”.
• Do not submit the notification twice – If your notification gets stuck, then, in this case, do not resubmit it. Instead, you can contact ECHA helpdesk for assistance.
• You can provide toxicological information in all relevant languages.

For more information or queries, please write to us at: compliance@gpcregulatory.com

11th – 12th November, 2020 | Koelnmesse, Germany.

Chemspec Europe, which is Europe’s major sourcing and networking event for fine and speciality chemicals industry, is scheduled to be held at Cologne, Germany on 11th and 12th November, 2020.

It is an ideal platform for the chemical industry, to present their new products and solutions as well as to identify synergies and business opportunities. The international trade show has become a powerful and well-known event in the industry and features the full spectrum of fine and speciality chemicals for various applications and industries, such as pharmaceuticals, agrochemicals, polymers and many others.

Being a service provider to the chemical industry, SSS would also be available this time around at Chemspec Europe and we look forward to meeting you at the event.

Please do visit us at Stall No. RS/J75.

Meet our experts: Our experts would be available for a one-on-one discussion on both the days. For your specific queries, you may book an appointment with our experts.

Please indicate your interest by writing to us at: compliance@gpcregulatory.com