GPC Newsletter Nov-2020


Announcement

RoHS is to restrict heavy metals, brominated flame retardants and phthalates use in electrical and electronic equipment. Increasing concerns about the environmental and health impacts of electronics expand geographical coverage of RoHS-like regulations. In our next Newsletter, we will bring you the latest updates of RoHs regulations around the world. 


Regulatory News

FCMs regulations are fast-moving to improve the protection of public health. Food contact materials (FCMs) refer to all materials and articles intended to come into contact with food, for example, packaging and containers, machinery to process food, kitchenware, tableware. In recent years, the safety of FCMs has become an issue and one of the major concerns is that chemicals can migrate from the materials into food and may adversely affect consumer health or/and influence the quality of the food. In responding to these concerns, EU and other countries have initiated FCMs regulations and the materials/articles must be manufactured in compliance with these regulations.

On 29th April 2020 the European Food Safety Authority adopted a scientific opinion that assigns salicylic acid, styrene and lauric acid, vinyl ester as high priority candidates for re-evaluation. This scientific opinion was issued upon the request of the European Commission to review the substances without a specific migration limit (SLM) in the Plastic Regulation (EU) No 10/2011. These substances were covered by the generic SML of 60 mg/kg of food, but with Regulation (EU) 2016/1416 this SLM was removed. Of these, 179 substances were placed into the low priority group, 102 were into medium priority group and 3 mentioned above into the high priority group for future re-examination of individual chemical. Existing hazard assessments for each chemical on carcinogenicity / mutagenicity / reprotoxicity, bioaccumulation and endocrine disruptor properties were considered for the prioritization procedure

On 20th May 2020, the European Commission issued new Farm to Fork Strategy, stating; “The Commission will revise the FCMs legislation to improve food safety and public (in particular in reducing the use of hazardous chemicals), support the use of innovative and sustainable packaging solutions using environmentally-friendly, re-usable and recyclable materials, and contribute to food waste reduction,” The Commission plans to publish the revision in the 4th quarter of 2022.

On 3rd September 2020, the European Union (EU) published Regulation (EU) 2020/1245 to amend and correct Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food. The 15th amendment added new substances to table 1 of Annex I and introduce several changes to Regulation (EU) 10/2011. The significant changes are summarized in table 1 below. The new law has entered into force as of September 23, 2020. In accordance with the transitional provision, plastic materials and articles that were placed on the EU market before March 23, 2021, and that comply with Regulation (EU) 10/2011 as applicable before the entry into force of this amendment may continue to be placed on the EU market until September 23, 2022 and remain on the market until the exhaustion of stocks.

 

Regulation (EU) 2020/1245 Amending and Correcting Regulations (EU) 10/2011

Section

Highlight

Annex I

Table 1. Union list of authorized monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids

1. A new detection limit of 0.002 mg/kg for 1,3-phenylenediamine (CAS 108-45-2)

2. Addition of three new entries

  • Montmorillonite clay modified with hexade-cyltrimethylammoniumbromide
  • Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly [oxy(methyl-1,2-ethane-diyl)], C10-16 alkyl ester
  • Titanium dioxide surface-treated with fluorine-modified alumina

Annex II

Restrictions on plastic materials and articles

Entire replacement of Annex II:

1. A new table 1 designates the Specific Migration Limit to 19 substances and other 5 substances whose migration limits are subject to Article 11(3) and Article 12

2. A limit of detection of 0.002 mg/kg food or food simulant for each primary aromatic amine (PAA) that is listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) 1907/2006

3. A limit of detection of 0.01 mg/kg for the sum of PAAs, which are not listed in entry 43 to Appendix 8 to Regulation (EC) 1907/2006. 

Annex IV

Declaration of compliance

Point 6 is replaced to include information on the amount of substances in intermediate materials

Annex V

Compliance testing

1. Amendment of point 2.1.3 to Chapter 2

Addition of new point (iv) that establishes rules for the migration of plastic materials or articles in food processing equipment or appliances

2. Entire replacement of point 2.1.6 to Chapter 2 ‘Repeated use materials and articles’

Migration test(s) shall be carried out three times on a single sample using a fresh portion of simulant on each occasion. The specific migration in each test must not exceed the level observed in preceding test.

3. Replacement of Table 3 under point 3.1 to Chapter 3 ‘Standardised conditions for testing the overall migration’

4. Replacement in point 3.2 and point 3.3.2 to Chapter

Table 1. Summary of 15th amendment of the Regulation (EU) 10/2011

 

 

The UK will exit the transition period on December 31, 2020.  From 2021, the EU REACH Regulation will be brought into UK law under the European Union (Withdrawal) Act 2018 and this chemical regulation is also known as UK REACH. REACH, and related legislation, will be replicated in the UK with the necessary changes to make it functional from 1st January 2021. The key principles of the EU REACH Regulation will be retained in UK REACH.

The Health and Safety Executive (HSE) will play a key role in the UK's chemicals regulatory process together with the Department for Environment, Food and Rural Affairs (Defra) and the Environment Agency (EA) to ensure the effective and safe management of chemicals to safeguard human health and the environment.

The Department for Environment, Food and Rural Affairs (Defra), early in September 2020, had announced tonnage band specific, staggered submission deadlines that will apply for the full submission of data. The full registration dossiers would hence need to be submitted within 2, 4 or 6 years, starting from October 28, 2021.

EU/EEA/non-UK manufacturers exporting to Great Britain may choose to appoint a GB-based OR to fulfil their UK REACH obligations. Substance registration via OR in this case will be considered as a new substance registration.  This would be classed as a new substance registration: full registration duties would apply, and the appropriate registration fee would be charged. If the EU/EEA/non-UK manufacturer’s GB-based OR registers within the relevant deadline, the GB importers would be treated as a downstream user under UK REACH, and would therefore not need to become registrants themselves. If the OR submits a notification of import or registers within 300 days of the end of the Transition Period, this will relieve their GB customer of the duty to notify the Health & Safety Executive (HSE) within 300 days. 

GB based downstream users or distributors may make use of the notification provision in the first instance, and consider further steps depending on their suppliers’ intentions in relation to the GB market. GB downstream users and distributors sourcing from the EU/EEA are advised to liaise with their suppliers, to ensure that a notification is completed by one or other party within 300 days of the end of the Transition Period. These measures apply only to existing UK downstream users or distributors under EU REACH who were, at any time in the 2-year period before 1st January 2021, already a downstream user or distributor under EU REACH established in the UK in relation to a substance.

According to the officials, an Only Representative (OR) will have to be a natural person or legal entity established physically in the UK and equipped with sufficient knowledge in the practical handling of the substances and information related to them; Appointed by a mutual agreement with a manufacturer, formulator or article producer, established outside the UK and responsible for complying with the legal requirements for importers under UK REACH.

Global Product Compliance (Europe) AB has already set up a UK based OR entity ‘GPC UK’, to support its existing and new potential clients, to be able to comply with the challenges posed because of Brexit on substance exports to the UK. 

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

 

On November 11.2020, the chemical registration IT System of KKDIK (Turkey REACH) was updated. The updated system is more user-friendly and slightly different than the previous one in terms of usage and information requirements.

Previously, registrants only needed to provide CAS or EC number of the substance and the name to be registered. In the updated version of the system, it is now obligatory to provide the information on tonnage band of substance in concern. Since tonnage band information was not a compulsory information before, all substances that were pre-registered in the previous version should be reviewed and updated with the tonnage band information.

In the new system, the way of pre-registration has also been changed: Now for each represented company a new profile is created through the Only Representative login and substances are managed separately in each profile. This way, it is expected to have easier segregation of different supply chains and downstream users in Turkey can easily notify themselves by simply adding the new profile as their supplier.

The deadline for pre-registration of KKDIK is fast approaching! After December 31, 2020, substances that have not been pre-registered will not be allowed to be placed in the Turkish market. Contact us at turkey-reach@gpcregulatory.com for KKDIK related services and check if you need to comply with KKDIK regulation and secure your business interests in Turkey before it is too late!

To ensure the implementation of Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No.12), MEE released the final version of Guidance on the application of MEE Order No.12 which is expected to come into force the same day as MEE Order No.12 on 1 January 2020. In the meantime, the previous guidance and its supporting measures issued in 2010 and data requirements issued in 2017 under MEP Order No.7 will be invalided.

This Guidance should be used together with MEE Order No.12 by applicants, agents and processing users. It contains guidance on registration scope, types, procedures, document and data requirement, special rules on polymer, new use management, certificates management, post-registration management and etc. Along with the guidance, relevant registration forms including registration application form, registration management form, information report form, and use code table are also released. Comparing to the previous scattered situation, MEE codified most of the requirements and instruction together into the Guidance and registration form instruction.

With the approaching of the implementation of MEE Order No.12, MEE published a transition measure – Notice on Transitional Arrangements for Environmental Management Registration of New Chemical Substance – on 27th October 2020. This measure aims to ensure the orderly continuity of new chemical substance registration activities during the transition period from MEP Order No.7 to MEE Oder No.12.

According to the transition measure, registration applications submitted under Order No.7 could still be processed under Order No.7 after the 1st January 2021when Order No.12 takes effect. But if a final decision hasn’t been made until 30th June 2021, the registration application has to follow the requirements under Order No.12. For those who obtain the certificates under Order No.7, they still have to fulfill the following obligations after the new regulation come into force next year.

For regular registration certificates holders:

  • Adopting environmental risk control measures according to the certificate requirements.
  • Information communication under Order No.12.
  • New use management applies to hazardous chemical substances characterized under article 3 of Order No.7.

For simplified registration certificate holders:

  • Information communication under Oder No.12.
  • Certificates obtained by research purpose is valid for 2 years since the first activity.

In case registrants wish to change any information on the registration certificate, they need to reapply under MEE Order 12. But changing of information mentioned below could be processed just by applying for changing of information under Article 30 of MEE Order No. 12.

Simplified Registration Certificate

Regular Registration Certificate

  1. The registration annual volume is lower than 1 ton after changing.
  2. Certificate is granted based on research purpose. After changing, the annual volume is lower than 10 ton and the certificate is within the valid period.
  3. Polymers which have less than 2% of monomers or belong to polymer of low concern
  1. Lower down the annual volume.
  2. Plan to change the activity types from producing to import or add import as one of the activities types.
  3. Plan to change the Chinese, English names or CAS number and etc. identification information.
  4. Plan to change applicant’s or agent’s names.


 

Ministry of Environment (MoE) in South Korea announced detailed rules for companies that do not want to disclose confidential business information under K-REACH. These new rules outline processes to get approval from the MoE along with official forms, which will come into force on 16 January 2021.

Businesses need to make an application to get approval. The application shall include reasons for not disclosing chemical information, and proof justifying the reasons. Approval is not required in cases where non-disclosure is already approved under the same rules or the Occupational Safety and Health Act (OSHA). Although non-disclosure is approved, businesses still need to provide substitute information in an MSDS if required.

Once an application is received, the Information Review Committee will check and evaluate the validity of the application, then provide the result within 30 days. The Committee might ask for additional information or interview. Applicants should respond to the Committee’s request, otherwise, the application will be withdrawn. In case the application is rejected, the applicant can appeal within 15 days after they received the result.

The MoE will review the rules every three years.

Affected stakeholders and implications

Companies who are subject to K-REACH and do not want to disclose chemical information due to confidentiality reasons can apply for non-disclosure of confidential information to the MoE. The new rules are applicable on 16 January 2021.

 

Last update: 11/10/2020 

On November 2, the Ministry of Environment (MoE) in South Korea announced the revised K-REACH rules. The reason is to ensure effective implementation of the K-REACH regulation. Four main revisions were proposed:

1. Registrants can have an extended deadline when changing the tonnage band and chemical usage of the registered substances

  • Currently, change registration should be completed within one month after the changes in quantities or the usage
  • Since toxicological data might be required due to changes in quantities and usage, the MoE makes it possible to extend the deadline of the change registration. It needs confirmation from the MoE and registrants can extend the deadline up to 1 year

2. Aligned confidentiality approval processes between the different competent authorities

  • The competent authority under K-OSHA, the Ministry of Employment and Labor (MoEL), and the MoE can now coordinate together and share the information. It is expected to ease registrants’ burden to go through different approval processes  

3. Integrated different terms for chemical Classification and Labelling used in various ministries

  • This will enhance consistency of the chemical Classification and Labelling and prevent confusion   

4. The government registration fees will be exempted for SMEs if they register their substances before 2022

  • This is to encourage SMEs to register their substances early and Only applicable for those who have a grace period until 2030

Affected stakeholders and implications

Registrants who need to change their tonnage band or chemical usage can have 1 year to prepare toxicological data after getting confirmation from the MoE.

SMEs do not need to pay the government registration fees if they register before 2022.

Industries can refer to the consolidated version of chemical Classification and Labelling in South Korea.

 

Last update: 11/17/2020

According to the amended Toxic and Concerned Chemical Substance Control Act, Taiwan’s EPA has to regularly review its fee scheme.

According to the proposed revision on “the Toxic Chemical Substances Handling Application and Chemical Substances Registration Fee Scheme” in September 2020, 25 % discount on the review fee is proposed for SMEs with additional discount possibilities if companies adopt alternative testing methods or submit their PECs registration one year ahead of the deadline.

At the public meetings, the EPA highlighted that registrants may submit the registration dossier without hazard and exposure assessments and the revised guideline for PEC standard registration may expand to multi-source data.

With 60 days for public comments, the EPA is expected to announce a new fee scheme and PECs registration deadlines.

Companies should expect longer time for dossier preparation and back-and-forth conversation within the supply chain. It is also important to note that join-registration is not mandatory. Contact GPC (compliance@gpcregulatory.com) to prepare your dossier now and gain lead time.

Source: https://flora2.eri.com.tw/seminarchemist/

On November 3rd 2020, Australian government announced that introducers (manufacturers or importers) of cosmetic toothpaste or oral hygiene products need to register their business only if their products meet the requirement of Therapeutic Goods (Excluded Goods) Determination 2018.  The ingredients used in cosmetic toothpaste or oral hygiene should categorized in any of the 5 main categories under AICIS.

Cosmetic toothpaste or oral hygiene products are those which meet the following criteria:

  • Do not contain any substance included in Schedules 2 (Pharmacy Medicine), 3, 4 or 8 to the Poisons Standard, these schedules contains list chemicals and controlled drugs which safe use may require advice from pharmacists or professionals.
  • Advertised or presented for supply so that the only benefits claimed to result from the use of the product are consequential on improvements to oral hygiene, including for the prevention of tooth decay or the use of fluoride for the prevention of tooth decay
  • Do not claim as therapeutic products

The registrants should keep records for 5 years of chemical introductions even after stopping introductions in Australia territory, to confirm that they comply with laws.

Registrants must submit annual declarations regardless the introduction category by 30 November after end of every registration year.

If toothpaste and oral hygiene products are medicines or marketed as having therapeutic effects, then they are classed as ‘therapeutic’ goods and regulated under Therapeutic Goods Administration (TGA) doesn’t have any implications under AICIS

Chemicals with CAS number 169118-66-5 and 144093-88-9 have been added to Australian Inventory of Industrial Chemicals in accordance with section 82 of the Industrial Chemicals Act 2019 after completion of 5 years since the assessment certificates were issued.

Information on Schedule 2,3,4 and 8:

Schedule 2: Pharmacy Medicine – Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.

Schedule 3:Pharmacist Only Medicine – Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.

Schedule 4: Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.

Schedule 8: Controlled Drug – Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.

Top