Regulatory Updates

Distribution date: 17 June 2021 | Final date for Comment: 16 August 2021

In September 2020, the Parliament approved the new regulations on explosives precursors. Explosives precursors may be used to make homemade explosives. The regulations adopted by the Parliament cover a number of products mainly sold in pharmacies, drugstores and specialist shops. No restrictions are laid down for low concentrations. When concentrations are higher, an authorization issued by fedpol shall be required for purchase. The law also provides for the prohibition of access to substances, as well as exceptions to this. The regulations are not applicable to professionals, such as farmers. The notified Ordinance specifies the eight substances covered by the restrictions and their limit values for access, in addition to the role of specialist shops. These shops know their clients well and may therefore freely sell certain substances in small quantities. In contrast to European legislation, the new Ordinance does not for the time being restrict access to sulphuric acid, which is often used in car batteries.

Products Covered: INORGANIC CHEMICALS; ORGANIC OR INORGANIC COMPOUNDS OF PRECIOUS METALS, OF RARE-EARTH METALS, OF RADIOACTIVE ELEMENTS OR OF ISOTOPES (HS code(s): 28); ORGANIC CHEMICALS (HS code(s): 29); PHARMACEUTICAL PRODUCTS (HS code(s): 30); FERTILISERS (HS code(s): 31); TANNING OR DYEING EXTRACTS; TANNINS AND THEIR DERIVATIVES; DYES, PIGMENTS AND OTHER COLOURING MATTER; PAINTS AND VARNISHES; PUTTY AND OTHER MASTICS; INKS (HS code(s): 32); SOAP, ORGANIC SURFACE-ACTIVE AGENTS, WASHING PREPARATIONS, LUBRICATING PREPARATIONS, ARTIFICIAL WAXES, PREPARED WAXES, POLISHING OR SCOURING PREPARATIONS, CANDLES AND SIMILAR ARTICLES, MODELLING PASTES, ‘DENTAL WAXES’ AND DENTAL PREPARATIONS WITH A BASIS OF PLASTER (HS code(s): 34); Propellent powders (HS code(s): 3601); Prepared explosives (excl. propellent powders) (HS code(s): 3602); Ferro-cerium and other pyrophoric alloys in all forms; metaldehyde, hexamethylenetetramine and similar products in tablets, sticks or similar forms, for use as fuel; alcohol-based fuels and prepared fuels of a similar kind, solid or in paste form; liquid gases and liquid fuels for lighters or igniters, in containers of

Regulation Type: Regular notification

Distribution date: 16 June 2021

Amendment to establish, amend and delete articles under the Minimum Requirements for Biological Products and the Public Notice on National Release Testing was adopted and published on 22 January 2021. The outline of amendment is available as attached file.

Products Covered: Pharmaceutical Products (HS: 30)

Regulation Type: Addendum to Regular Notification

Distribution date: 16 June 2021

National Institute of Metrology, Quality and Technology - Inmetro, issued Ordinance No. 251, 09 June 2021 that approves the consolidated metrological technical regulation on net contents of pre-packaged goods. Inmetro Ordinance No. 251 revokes on the effective date of adoption: -       Ordinance Inmetro No. 153, of 19 May 2008, published in the Official Gazette on 21 May 2008, section 1, page 91; -       Ordinance Inmetro No. 258, of 24 July 2008, published in the Brazilian Official Gazette on 28 July  2008, section 1, pages 61 to 62; -       Ordinance Inmetro No. 69, of 15 February 2016, published in the Brazilian Official Gazette on 16 February 2016, section 1, page 38; and -       Ordinance Inmetro No. 103, of 12 March 2019, published in the Brazilian Official Gazette on 22 March 2019, section 1, page 15.

Products Covered: Net content of frozen fish fillet, toothpaste, bar wash soap and solid bleach – HS: 0304 Fish fillets frozen (whether or not minced); 3306 Preparations for oral or dental hygiene toothpaste 340211 Soap bars; 2828 Hypochlorites; commercial calcium hypochlorite; chlorites; hypobromites.

Regulation Type: Addendum to Regular Notification

Distribution date: 15 June 2021

The Resolution disposes about the mandatory execution and notification of field actions by product registration holders for health in Brazil.

Products Covered: Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 14 June 2021 | Final date for Comment: 13 August 2021

This Draft Uganda Standard specifies general requirements, sampling and test methods for garments, whether made of textile, plastic-coated fabric, fur or any combination of these materials.  Requirements for specific garments are specified in the relevant parts of DUS 1970. This draft Standard does not apply to personal protective wear.

Products Covered: (HS code(s): 62); (ICS code(s): 61.020)

Regulation Type: Regular notification

Distribution date: 14 June 2021 | Final date for Comment: 13 August 2021

This Draft Uganda Standard specifies requirements, sampling and test methods for briefs for men and women

Products Covered: (HS code(s): 6107, 6108); (ICS code(s): 61.020)

Regulation Type: Regular notification

Distribution date: 14 June 2021 | Final date for Comment: 13 August 2021

This Draft Uganda Standard specifies requirements, sampling and test methods for men’s and boys’ boxer shorts 

Products Covered: Boxers

Regulation Type: Regular notification

Distribution date: 10 June 2021 | Final date for Comment: 09 August 2021

This document applies to the production and supply of ready-mixed concrete for buildings and civil engineering structures cast in situ. The standard applies to ready-mixed concrete delivered to the purchaser in an unhardened, plastic state. This standard also outlines the mechanism to demonstrate compliance to these requirements and includes measures to be taken in the event of non-compliance. 

Products Covered: Non-refractory mortars and concretes (HS code(s): 382450); Concrete and concrete products (ICS code(s): 91.100.30)

Regulation Type: Regular notification

Distribution date: 09 June 2021 | Final date for Comment: 08 July 2021

Draft resolution of risk assessment and control of potentially carcinogenic nitrosamines in medicines for human use.

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: 09 June 2021

The draft revision to establish Japanese Pharmacopoeia, Eighteenth edition notified in G/TBT/N/JPN/677 has been adopted and published on dated 7 June 2021. Japanese Pharmacopoeia, Eighteenth edition in English is planned to be published in due course.

Products Covered: Pharmaceutical Products (HS:30)

Regulation Type: Addendum to Regular Notification