Regulatory Updates

Distribution date: 17 August 2023 | Final date for Comment: 16 October 2023

This Draft East African Standard specifies requirements, methods of sampling and test for organic fertilizers. 

Products Covered: Animal or vegetable fertilisers, whether or not mixed together or chemically treated; fertilisers produced by the mixing or chemical treatment of animal or vegetable products. (HS code(s): 3101); Fertilizers (ICS code(s): 65.080) ; Organic Fertilizers

Regulation Type: Regular notification

Distribution date: 15 August 2023

Normative Instruction 157, 13 May 2022 - previously notified through G/TBT/N/BRA/1399 - which contains provisions on ontains provisions on the inclusion of the declaration about new formula in the labeling of sanitizing products when change its composition, was revoked by Normative Instruction 243, 09 August 2023.  The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6633079/IN_243_2023_.pdf/ecaad49f-7c0f-4c61-80c1-6c13544075e6 

Products Covered: Lubricating preparations (including cutting-oil preparations, bolt or nut release preparations, anti-rust or anti-corrosion preparations and mould release preparations, based on lubricants) and preparations of a kind used for the oil or grease treatment of textile materials, leather, furskins or other materials, but excluding preparations containing, as basic constituents, 70 % or more by weight of petroleum oils or of oils obtained from bituminous minerals. (HS code(s): 3403)

Regulation Type: Addendum to Regular Notification

Distribution date: 15 August 2023

The resolution 768, 12 December 2023 - previously notified through  G/TBT/N/BRA/1024/Add.1 - which establish rules for drug labeling, was changed by Resolution 808, 04 August 2023. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/3426875/RDC_808_2023_.pdf/18f7326c-eab1-4e6a-acea-f31a9cb10887 

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 11 August 2023 | Final date for Comment: 10 October 2023

The Order seeks to ensure conformity of the Poly Vinyl Chloride (PVC) Homopolymers to the Indian Standard, as amended from time to time, as specified in the Table of the Order. 

Products Covered: Poly Vinyl Chloride (PVC) Homopolymers (IS 17658:2021)

Regulation Type: Regular notification

Distribution date: 10 August 2023

RDC – Resolution n. 530, August 11th, 2021 - previously notified through G/TBT/N/BRA/1238 - which provides for the list of substances that personal hygiene products, cosmetics, and perfumes must not contain except under the conditions, and with the established restrictions, the list of fragrance and aroma components that must be indicated and internalizes GMC MERCOSUR Resolution n. 24/11, amended by GMC MERCOSUR Resolution n.37/20, was changed by Resolution 806, 03 August 2023. Resolution 806, 03 August 2023, internalizes GMC MERCOSUR Resolution nº 35/22 (https://normas.mercosur.int/public/normativas/4440) The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6637181/RDC_806_2023_.pdf/dd04a0b7-0d78-44ab-8402-24983c8488ae 

Products Covered: HS Code(s): 3303; 3304; 3305; 3306; 3307; 340111; 340130; 9616; 9619 (personal hygiene products, cosmetics, and perfumes)

Regulation Type: Addendum to Regular Notification

Distribution date: 10 August 2023

This normative instruction contains provisions on the inclusion of declaration of new formula in hygiene product labeling personal, including disposables, cosmetics and perfumes when formula modification.  

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33)

Regulation Type: Regular notification

Distribution date: 10 August 2023 | Final date for Comment: 25 September 2022

This draft resolution contains provisions on the conditions and procedures for registering pre-pandemic influenza vaccines, updating to a pandemic strain and authorization for the use, marketing and monitoring of pandemic influenza vaccines. It is important to highlight that, when the absence or incompleteness of national regulation, and as long as there is no incompatibility, the adoption of guides and guidelines by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 10 August 2023 | Final date for Comment: 28 August 2023

This Draft Resolution contains provisions on health requirements for safety and efficacy for post-marketing registration alterations of synthetic and semi-synthetic drugs classified as new or innovative.

Products Covered: Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 10 August 2023 | Final date for Comment: 28 August 2023

This Draft Resolution contains provisions on definition, classification, technical requirements for labeling and packaging, parameters for microbiological control, as well as technical requirements and procedures for the regulation of personal hygiene products, cosmetics and perfumes.

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33)

Regulation Type: Regular notification

Distribution date: 10 August 2023

Normative Instruction 162, 01 July 2022 - previously notified through  G/TBT/N/BRA/1417 - which establishes  the  acceptable  daily intake  (ADI),  the  acute  reference  dose  (DRfA)  and  maximum  residue  limits  (MRL)  for active pharmaceuticals ingredients (API) of veterinary drugs in foods of animal origin, was changed by Normative Instruction 241, 03 August 2023.   The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6637201/IN_241_2023_.pdf/dd2c2335-48ad-4bfb-b807-cb69ea5b9e94

Products Covered: Pharmaceutical goods specified in Note 4 to this Chapter. (HS code(s): 3006)

Regulation Type: Addendum to Regular Notification