Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up
Distribution date: 07 April 2020 | Final date for Comment: 06 June 2020
This draft Regulation relates to a new entry of Annex XVII to Regulation (EC) No 1907/2006. It would restrict the placing on the market and the use of substances in mixtures for use for tattooing purposes. These substances are: (i) substances with harmonised classification under Regulation (EC) No 1272/2008 (CLP) as carcinogenicity, mutagenicity or toxicity to reproduction, skin sensitisation, skin corrosion or irritation and serious eye damage or irritation; (ii) substances prohibited by the Cosmetic Products Regulation, Regulation (EC) No 1223/2009 Annex II and Annex IV under specific conditions as listed in its columns g, h and i and (iii) impurities exceeding the concentration limits as listed in the Appendix to the draft Commission Regulation. Application of the restriction is deferred for 1 year to allow sufficient time to adapt and achieve compliance with the Regulation.
Products Covered: Tattoo inks or permanent make-up
Regulation Type: Regular notification
Draft Resolution number 805, 27 March 2020
Distribution date: 07 April 2020 | Final date for Comment: 05 August 2020
This resolution establishes administrative procedure for the concession of Good Manufacturing Practices Certification for medicines, medical devices, personal hygiene products, cosmetics, perfumes, sanitizers, active pharmaceutical ingredients, and food; and Good Practices of Storage and Distribution Certification for medicines, medical devices, and active pharmaceutical ingredients.
Products Covered: HS Code(s): 2106, 29, 2936, 2937, 2941, 3303, 3304, 3305, 3306, 3307, 340111, 340130, 3402, 340119, 340120, 330290, 9616, 9619; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft Resolution number 804, 27 March 2020
Distribution date: 07 April 2020 | Final date for Comment: 30 May 2020
This draft resolution establishes the exclusion of the active ingredients A48 – Aviglicina (aviglycine); B25 – Butralina (butralin); D23 – Dissulfotom (disulfoton); D42 – Dinocape (dinocap); F57 – Fenotiol (fenotiol); F60 - Flufenpir (flufenpir); O17 – Octanoato de ioxinila (Ioxynil octanate) e T10 – Tetradifona (tetradifon) from Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE no. 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003 due to no formulated products with those active ingredients having marketing authorization.
Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65
Regulation Type: Regular notification
SI 47 - Motor vehicle brake fluids
Distribution date: 07 April 2020 | Final date for Comment: 06 June 2020
The existing Mandatory Standard, SI 47, dealing with motor vehicle brake fluids, shall be declared voluntary. This declaration aims to remove unnecessary obstacles to trade and lower trade barriers.
Products Covered: Motor vehicle brake fluids
Regulation Type: Regular notification
Dossier for Active Pharmaceutical Ingredient (API) in the market authorization and post-market authorization of medicines The Draft Resolution number 683 – previously notified through G/TBT/N/BRA/904 – which proposes the changing of the Resolution – RDC number 200, 26 December2017, and of the RDC number 73, 7 April 2016, for the submission of the Dossier for Active Pharmaceutical Ingredient (API) in the market authorization and post-market authorization of medicines, respectively, was adopted as Resolution – RDC number 361, 27 March 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 08 April 2020 | Final date for Comment: 10 May 2025
Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)
Regulation Type: Addendum to Regular Notification
Certification of Good Manufacturing Practice for international companies that manufacture Active Pharmaceutical Ingredients (API) The Draft Resolution number 688, 12 August 2019 – previously notified through G/TBT/N/BRA/900 – which establishes criteria for certification of Good Manufacturing Practice for international companies that manufacture Active Pharmaceutical Ingredients (API) – was adopted as Resolution – RDC number 362, 27 March 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 08 April 2020 | Final date for Comment: 10 May 2025
Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)
Regulation Type: Addendum to Regular Notification
Establishment of the Dossier for Active Pharmaceutical Ingredient (API) and of the Adequacy Charter of the Dossier for Active Pharmaceutical Ingredient The Draft Resolution number 682 – previously notified through G/TBT/N/BRA/905 – which proposes the establishment of the Dossier for Active Pharmaceutical Ingredient (API) and of the Adequacy Charter of the Dossier for Active Pharmaceutical Ingredient – was adopted as Resolution – RDC number 359, 27 March 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 08 April 2020 | Final date for Comment: 10 May 2025
Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)
Regulation Type: Addendum to Regular Notification
KS 2228: 2020 Foliar fertilizer (inorganic)—Specification
Distribution date: 08 April 2020 | Final date for Comment: 07 June 2020
This Kenya Standard specifies the requirements and prescribes methods of tests for inorganic foliar fertilizers.
Products Covered: (HS code(s): 31); Fertilizers (ICS code(s): 65.080)
Regulation Type: Regular notification
TITLE: Electronic Detonators AGENCY: Mine Safety and Health Administration, Labor ACTION: Direct final rule; confirmation of effective date SUMMARY: The Mine Safety and Health Administration (MSHA) confirms the effective date for the direct final rule, Electronic Detonators, which was published on 14 January 2020, to revise certain safety standards for explosives at metal and nonmetal mines. DATES: The effective date of the final rule published in the Federal Register of 14 January 2020 (85 FR 2022) is confirmed: 16 March 2020. The docket folder on Regulations.gov provides access to primary documents for this rulemaking as well as comments received: https://www.regulations.gov/docket?D=MSHA-2019-0007.
Distribution date: 08 April 2020 | Final date for Comment: 10 May 2025
Products Covered: Electronic detonators
Regulation Type: Addendum to Regular Notification
KS 2220: 2020 Magnesium sulphate fertilizer—Specification
Distribution date: 08 April 2020 | Final date for Comment: 07 June 2020
This Kenya Standard specifies the requirements, methods of sampling and tests for magnesium sulphate fertilizer.
Products Covered: (HS code(s): 31); Fertilizers (ICS code(s): 65.080)
Regulation Type: Regular notification
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