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GPC Newsletter Jun-2020


Announcement

Global Product Compliance (GPC) Group is glad to announce that Dr. Jayachandran Nair has joined us as the CEO of GPC India.

Dr. Nair is a leading professional in the areas of Environment and Global Chemical Regulations and has brought his 20+ years of experience to lead GPC India. He founded and heads Trust House Solutions (THS) - a nationwide trusted name for chemical regulatory compliance services. From 2020 THS and GPC India works as close business strategic partners.

His focus areas involve global regulatory compliance, capacity building, strategic planning, and strengthening in-house resources for industries.

He is a key stakeholder and promoter of GPC activities globally and as CEO - GPC India will lead a team of 75+ professionals in 3 locations across India. He would also continue to work closely with the senior team at GPC Group along with other regulatory executives that are currently in contact with your respective organizations.

Here forward GPC Group entrusts Dr. Nair to further nurture the company’s founding ideology of mutual growth.


Regulatory News

A South Korean industry support group published a list of 332 substances that require prompt CICO (Chemical Substance Information Communicative Organization) establishment. These substances are the cases where pre-registrants of a concerning chemical have not selected a Lead Registrant (LR) or no activities have been observed. The industry support group released this list to raise concerns over the registration deadline on 31 December 2021.

Manufacturers and importers of existing chemicals in quantities exceeding 1 ton per year shall register their chemical substances before grace periods. The grace periods depend on the tonnage of the manufactured and imported chemicals, which are described below.

Substance type

Registration deadline

>=1000t/y existing substances
>=1t/y designated CMR substances

31 December 2021

100-1000t/y existing substances

31 December 2024

10-100t/y existing substances

31 December 2027

1-10t/y existing substances

31 December 2030

Manufacturers and importers should initiate dossier preparation and communicate with other co-registrants and LR in a CICO to register existing substances at more than 1000 tons per year and designated CMR substances at more than 1 ton per year by the registration deadline (31 December 2021).

What to do next?

If you are exporting to South Korea and your substance falls under the list, especially if you are exporting more than 1000 tons per annum, we suggest you contact us as soon as possible to not get affected by the upcoming deadline and continue your business in South Korea without any loss.

While there are less than 160 days left for the first phase for Turkey’s REACH regulation to conclude, more than 18,000 substances were pre-registered already by the first half of 2020, reportedly.

Pre-registration (or more accurate pre-SIEF notification) has begun on 23rd December 2017 and companies including local manufacturers and importers, as well as non-Turkish manufacturers through only representatives have been submitting their substances via KKS (Chemical Registration System) on the Ministry of Environment and Urbanization’s e-portal.

It is reported that as of 23rd of June 2020, 872 companies have submitted 77,037 notifications for 18,227 substances to comply with the REACH regulation, KKDIK, which came into force on 23rd of June 2017. As KKDIK does not allow for late pre-registration, companies that have not yet pre-registered their substances are encouraged to do so as early as possible before the 31 December 2020 deadline to not experience loss of business in the Turkish market.

As the number of pre-registered substances grows day-by-day, it is expected for the Ministry to soon publish the official registration fees for different tonnage bands as well as the candidate substances to be included in Annex 14 - authorization list, since the beginning of the registration phase is approaching meanwhile.

To not miss the deadline and experience business loss, you can send us the list of your substances for a free assessment and learn which substances you have to pre-register. You can also check our FAQ for Turkey REACH or contact us for further queries.

Source: Chemical Watch

The Substances of Concern In articles as such or complex objects (Products) also known as the SCIP database is a new requirement under the Waste Framework Directive. Companies that supplying articles containing SVHCs on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market have to notify ECHA from 5 January 2021.

The idea of the SCIP database is to ensure information about substances of very high concern (SVHCs) is available throughout the whole life cycle of products and materials, including at the waste stage. ECHA plans to release SCIP v1 by the end of October 2020 and the database will be open to receive data to fulfill a legal obligation.

A new version of IUCLID is also updated on the ECHA Cloud Services. Registrants who are preparing for SCIP notifications can use article referencing function in IUCLID.

GPC recommends companies to know the portfolio of their articles or complex objects, prepare an inventory, and have an initial screening of the materials that contain SVHCs on the candidate list in a concentration above 0.1% (w/w).

GPC will organize a free webinar event on the SCIP database and its implications on Substances in Articles on 4 August (Register here). In this webinar, we will introduce the SCIP Notification process and compliance strategies for Non-EU suppliers.

Source: ECHA, IUCLID

To support the introducers under current Australian chemical regulation (AICIS), authorities have rolled out minor improvements in categorization along with adding few chemicals in the inventory (The Australian Inventory of Chemical Substances (AICS)).

Minor changes to the Categorisation Guidelines:

After consultation with stakeholders, authorities have made minor/editorial changes on:

  • Information prerequisites for:

  1. UV filters
  2. Chemicals with an end-use in tattoo inks
  3. Highly branched organic chemicals, and
  4. Chemicals with an end-use as a biocidal active.

  • Waiver of persistent and bio-accumulative hazard characteristics for high molecular weight polymers. 
  • Derek Nexus in silico model can now be used for more human health hazard characteristics. 
  • The term NOEC (no observed effect concentration) has been removed while talking about acute aquatic toxicity, as NOEC is only relevant for chronic aquatic toxicity. 

The following are progressions implemented under the new scheme. 

Chemicals added to the Inventory:

  • Chemicals with CAS numbers 13431-57-7, 131796-64-0, 762300-77-6, 2231434-98-1, 85711-34-8, 85711-55-3, and 97404-53-0 are now listed on the AICS.
  • Chemicals with CAS numbers 2417117-63-4, 18721-51-2, 72065-17-9, 52238-01-4, 1627852-91-8, 1469871-11-1, and 1243578-28-0 are presently taken to be listed on the AICS, 5 years after issuance of assessment certificate.

Chemicals with Non-industrial Use:

After extensive review, chemicals with non-industrial uses were identified and removed from the Australian Inventory of Chemical Substances (old Inventory).

More than 1600 chemicals are now NOT listed under new inventory. The complete list of 1600 chemicals can be obtained from the Australian Government’s Industrial Chemicals Website.

For more details please contact us at compliance@gpcregulatory.com

To support the introducers under current Australian chemical regulation (AICIS), authorities have rolled out minor improvements in categorization along with adding few chemicals in the inventory (The Australian Inventory of Chemical Substances (AICS)).

Minor changes to the Categorisation Guidelines:

After consultation with stakeholders, authorities have made minor/editorial changes on:

  • Information prerequisites for:

  1. UV filters
  2. Chemicals with an end-use in tattoo inks
  3. Highly branched organic chemicals, and
  4. Chemicals with an end-use as a biocidal active.

  • Waiver of persistent and bio-accumulative hazard characteristics for high molecular weight polymers. 
  • Derek Nexus in silico model can now be used for more human health hazard characteristics. 
  • The term NOEC (no observed effect concentration) has been removed while talking about acute aquatic toxicity, as NOEC is only relevant for chronic aquatic toxicity. 

The following are progressions implemented under the new scheme. 

Chemicals added to the Inventory:

  • Chemicals with CAS numbers 13431-57-7, 131796-64-0, 762300-77-6, 2231434-98-1, 85711-34-8, 85711-55-3, and 97404-53-0 are now listed on the AICS.
  • Chemicals with CAS numbers 2417117-63-4, 18721-51-2, 72065-17-9, 52238-01-4, 1627852-91-8, 1469871-11-1, and 1243578-28-0 are presently taken to be listed on the AICS, 5 years after issuance of assessment certificate.

Chemicals with Non-industrial Use:

After extensive review, chemicals with non-industrial uses were identified and removed from the Australian Inventory of Chemical Substances (old Inventory).

More than 1600 chemicals are now NOT listed under new inventory. The complete list of 1600 chemicals can be obtained from the Australian Government’s Industrial Chemicals Website.

For more details please contact us at compliance@gpcregulatory.com

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