GPC Newsletter Dec-2020

RoHS stands for Restriction of Hazardous Substances, which is specific, applies to electrical and electronic equipment (EEE). It aims to prevent pollution in product design, purchase, and production phases by restricting the use of harmful chemicals such as heavy metals, brominated flame retardants, and phthalates in such products. In the EU/EEA, RoHS prevents the use of certain chemicals in EEEs above a threshold of 1000 ppm, and sets out requirements to be applied by manufacturers, importers and distributors throughout the supply chain (CE marking, traceability, conformity assessments etc.). This month, the Newsletter team at GPC brings to you a Global Overview on RoHS and to stay updated on how increased concern over environmental and health impacts of electronics boost the RoHS-like regulations around the world.

The report content contains:

  • What is RoHS?
  • Impacts of RoHS on the electronic industry
  • From the EU RoHS to global Standards
  • Current challenges
  • How are electric and electronic toys regulated?
  • Way forward

Please click here to read our report A Global Overview on the RoHS.



Regulatory News

The amended SEA Regulation, the “Bylaw on Classification, Labeling and Packaging of Substances and Mixtures” (the CLP regulation) in Turkey, was published on 10 December 2020 in the Official Gazette No.31330. This amendment harmonized the EU CLP 13th Adaptation to Technical Progress (ATP) but excluding 12th ATP. Important updates are summarized here:  

  • Nearly 110 substances were added to the classification list in Article 6 

  • New hazards classification was added to the 108 substances  

  • Notification applies to not only hazardous substances but all substances subject to KKDIK registration 

  • Annexes 7-11 were removed to avoid redundancy from implementing KKDIK  

  • This new amendment has two-years-transition periods, which reclassification and relabeling applies for substances and mixtures being placed on the market after 1 January 2023  

  • KKDIK registered substances are exempted from classification and labeling notification 

  • Mandated Poison Center Notification by 1 January 2025  

The Central Government of India in exercising its powers conferred by section 16 of the Bureau of Indian Standards (BIS) Act (2016) prepared the following amendments in the orders that were published by the Ministry of Chemicals and Fertilizers, Department of Chemicals and Petrochemicals:

  1. Pyridine (Quality Control) Order, 2020
  2. Gamma Picoline (Quality Control) Order, 2020
  3. Beta Picoline (Quality Control) Order, 2020
  4. Potassium Carbonate (Quality Control) Order, 2020
  5. Sodium Tripolyphosphate (Quality Control) Order, 2020 and
  6. Hydrogen Peroxide (Quality Control) Order, 2020

Due to Covid-19 disruptions, the Government of India has postponed the implementation date of these orders from 4th Dec. 2020 to 13th June 2021. 

 

 

The “Occupational Safety and Health Act” was revised on January 15, 2019 and came into effect from January 16, 2020. In relation to this Act, the “Material Safety Data Sheet” (MSDS) was recently revised and will be effective from January 16, 2021. Summary of the revised MSDS regulation in Korea:

  • The definition of MSDS preparation and submitter is changed to a person who manufactures or imports (revised) chemical substances, etc. (Initially it was a person who transfers or provides chemical substances)
  • Health functional foods and hygiene products have been added to the exclusion of MSDS preparation and submission.
  • For R&D chemical substances, MSDS must be prepared, but submission obligations are exempt.
  • If MSDSs are not submitted, a penalty of 5 million won (KRW) or less will be applicable.
  • Previously it was possible for companies to hide name and content of the ingredients to secure the trade secret and recipes of the products. However as per the revised laws, an approval from Minister of Employment and Labor is required.
  • Research and development (R&D) chemicals are subject to closed review, but the review process is simplified
  • As per the revised regulation an administrative fine of not more than 5 million won (KRW) will be imposed on those who write alternative data without the approval of the Minister of Employment and Labor and those who do not provide the alternative name and content information despite the request for non-public information.
  • If a chemical substance is likely to cause serious health hazards to workers then its information shall be submitted and notified to the Minister of Employment and Labor after deliberation by the Workers' Compensation Committee''

 

Korea MSDS – Comparison with the previous version

Division

Before revision (current)

After revision

Remark

MSDS Preparation target (scope)

•Hazardous/dangerous chemicals and formulations containing them

•Abbreviation (target chemical substance)

•Hazardous/dangerous chemicals or mixtures

•Abbreviation (substance subject to MSDS)

Only the abbreviations are changed

Subject of MSDS

•Transfer and provider of target substances

• Manufacture and importer of substances subject to MSDS

•Non-Korean manufacturers need to appoint OR for MSDS under KOSHA.

Item to be listed on MSDS

•Substance name

•Product Name

New provision to add trade name in the MSDS

 

*(Example) Write the product name “Crenetanol”, not “Ethyl alcohol” as the component

•Name and content of all ingredients

• Name and content of hazardous and dangerous chemical substances among the components

Only hazardous components are required to be mentioned

 

*(Example) “Ethyl alcohol 92%”

MSDS Submission

•Unregulated

•Submission to the Minister of Employment and Labor

•MSDS is received and managed by the government(authority)

 

Submission of information, etc. by a person appointed by a foreign manufacturer (Article 113 of the Industrial Safety Act)

Division

Before revision (current)

After revision

Required Documents

Appointment Requirements

Unregulated

⦁A citizen of the Republic of Korea or a person with an registered entity (in the case of a corporation) in Korea

-

Appointment Method

⦁Report of appointment or dismissal is submitted to the head of the competent local employment and labor office.

*Enforcement rules

[Attachment No. 68 Form]

Appointment Result

⦁Local employment and labor office issues a report within 7 days

-

Tasks to be performed

⦁Preparation and submission of MSDS, Submission of the name and content of chemical substances or confirmation documents

⦁Approval of writing substitute data, approval for extension of validity period, and appeal

-

Information to be provided

⦁The appointed OR must provide the MSDS and related work results to the importer along with a copy of the report.

OR Appointment confirmation (copy),

MSDS, etc.

※ Additional data need to be submitted: proof of appointment (dismissal), such as proof of appointment requirements and a copy of the appointment contract

 

Special cases (grace period) for preparing and submitting MSDS

ㅇ Persons who have created or modified the existing MSDS according to the previous legislation at the time of enforcement date (January 16, 2021) (limited to those who manufactured or imported the target chemical substance among those who transferred or provided the target chemical substance) MSDS and data on the name and content of chemical substances must be submitted by the date determined by Ordinance of the Ministry of Labor.

Annual manufacturing/import volume

Submission deadline

Annual manufacturing and import of materials subject to material safety data sheets is 1,000 tons or more

January 16, 2022

Annual manufacturing and import of materials subject to material safety data sheets is between 100-1,000 tons

January 16, 2023

Annual manufacturing and import of materials subject to material safety data sheets is between 10-100 tons

January 16, 2024

Annual manufacturing and import of materials subject to material safety data sheets is between 1-10 tons

January 16, 2025

Annual manufacturing and import of materials subject to material safety data sheets is below 1ton

January 16, 2026

※ The ‘Days determined by Ordinance of the Ministry of Employment and Labor’ in Article 8 of the Supplementary Regulations of the Industrial Safety Act No.

 

Last update: 12/11/2020

The EPA showed its intention to grant the extension of the deadline for Standard Registration of 106 PECs as chemical manufacturing and import associations in Taiwan raised their concerns over the preparation for dossiers in public seminars in October this year. Now the EPA has confirmed to extend the deadline of Standard Registration to Dec. 31, 2020, regardless of the tonnage.

Currently, registrants can get the registration number of Standard Registration even if they have not submitted hazard and exposure assessment (Item 8 and 9 in dossier report). The date for later submission of these two items will be clarified later when the guidance is updated.

The Australian Department of Health (DOH) announced guidance for manufacturers and importers of chemicals that have an end-use in food-contact articles. The guidance shares six steps to categorize food-contact chemicals as “exempted”, “reported”, or “assessed”, while chemicals that are on their inventory are categorized as “listed”.

The guidance provides examples of food-contact articles such as food wrapping, food containers, coatings on the inside of food cans, and coatings on the insides of water storage tanks. However, chemicals used in cardboard, glass, or metal packaging that has no direct contact with food are not included in this scheme. Moreover, it classifies industrial chemicals introduced for an end-use in food-contact materials as a ‘specified class of introduction’ due to their potentials of migrating to food.

DOH shares the record-keeping obligations for exempted or reported introductions of a chemical for use in food-contact materials. The aim of the record-keeping, according to the DOH, is to ensure chemicals do not pose human health and environment hazard characteristics. The guidance requires to keep the following records in case the new substances have not been internationally evaluated for human health.

  • Data approved by other national authorities for the use of the substance in food contact articles, if available
  • Data on the possibility of the substance migrating to food

Are you introducing soaps into Australian territory for commercial purposes to make a profit? Then you must register under AICIS. The registration duty applies only if soaps manufactured in Australia involving a chemical reaction (such as saponification using lye), importing soaps or their ingredients (essential oils, fragrance) for soap making intended for sale. 

The registration starts on 1st September and ends on 31st August every year, and registration expenses are primarily based on your previous financial year’s total importation and manufacture value. 

Before going for registration, introducers need to check whether all the ingredients in soap, are to be had in the Australian chemical inventory. if not then ingredients need to be registered.  

The registration obligation does not imply to those who make or buy soap for personal use, bought from local Australian shop, supplier, or manufacturer, and make soap and gift to family and friends or sell them for no profit. 

Soap-making process 

Description process 

Registration Obligation 

Cold-process 

Saponification 

Yes if intend to sell for profit) 

Hot-process 

Saponification 

Yes (if intend to sell for profit) 

Mixing & blending  

If using soap bases, glycerine blocks and pre-made, melt-and-pour bases purchased from an Australian supplier, the chemical process has already occurred. 

No  

 

Click here to see more on compliance obligations for soap makers under AICIS. 

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