Regulatory Updates

Distribution date: 01 July 2021 | Final date for Comment: 30 August 2021

The technical regulations for the classification, labelling and packaging of substances and preparations will be updated and thus adapted to technical progress in the EU (16th and 17th ATP of the EU CLP Regulation; binding from 1 March 2022). This draft revision updates the list of harmonized classifications: inclusion of 22 substances; amendment of 41 existing entries With this draft revision, the latest developments in test methods for substances and preparations (OECD) are adopted. Two substances are included in the candidate list of substance of very high concern. This listing triggers information obligations along the supply chain.

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); MISCELLANEOUS CHEMICAL PRODUCTS (HS code(s): 38); Protection against dangerous goods (ICS code(s): 13.300); CHEMICAL TECHNOLOGY (ICS code(s): 71)

Regulation Type: Regular notification

Distribution date: 30 June 2021

The purpose of the notified Law is to create the National Health Regulatory Authority, as a public entity with legal personality, its own assets and technical and administrative autonomy. The National Health Regulatory Authority is attached to the Ministry of Health and has full capacity to acquire rights and contract obligations concerning matters within its competence, and will be the uninterrupted legal successor of the Directorate-General of Health Regulation, established by Decree No. 25-2006 amending and supplementing Decree No. 71-98, Regulations implementing Law No. 290, Law on the Organization, Competence and Procedures of the Executive, published in La Gaceta, Official Journal Nos. 91 and 92 of 11 and 12 May 2006. It currently operates as the Directorate-General of Health Regulation in accordance with the institutional organizational chart. This entity will be known by the acronym ANRS and will be domiciled in the city of Managua. The purpose of the ANRS will be to facilitate, regulate, implement, develop and coordinate policies, laws, regulations and standards concerning health authorizations, surveillance, promotion, advertising, control and inspection of: medicines (breast milk and breast milk substitutes), vaccines, biological and biotechnological products; natural homeopathic and medicinal products; food and beverages; nutritional supplements; medical devices and other health-related technology; all products relating to ionizing radiation; precursor chemicals; cosmetic and hygiene products; and tobacco and tobacco products. Its purpose will also be to: regulate and control donations, foreign medical brigades, medical and non-medical inputs; and regulate professional health practices, audits on the quality of health-care services, establishments providing health services, pharmaceutical and non-pharmaceutical establishments, food establishments, and establishments providing disinfection, structural or housing sanitation services using pesticides, toxic, hazardous and other similar substances; and others that may have an impact on health.

Products Covered: HS codes: 10, 11, 12, 15, 16, 17, 18, 19, 20, 21, 22, 24, 30, 903010, 04, 09; ICS codes: 11.140, 67.020, 67.040, 67.060, 67.100, 67.140, 67.160, 67.180, 67.190, 67.200, 67.220, 67.230, 67.250, 67.260, 13.280, 65.160, 11.100.01, 11.120.01, 11.120.10

Regulation Type: Regular notification

Distribution date: 29 June 2021 | Final date for Comment: 28 August 2021

The purpose of the notified draft Resolution is to establish requirements for the registration of manufacturers, formulators, packers and importers of fertilizers, soil conditioners and related products for agricultural and garden use and other provisions, with a view to minimizing associated health and environmental risks and protecting plant health in Colombia.

Products Covered: Fertilizers, soil conditioners and related products for agricultural and garden use

Regulation Type: Regular notification

Distribution date: 29 June 2021

The purpose of the notified Law is to create the National Health Regulatory Authority, as a public entity with legal personality, its own assets and technical and administrative autonomy. The National Health Regulatory Authority is attached to the Ministry of Health and has full capacity to acquire rights and contract obligations concerning matters within its competence, and will be the uninterrupted legal successor of the Directorate-General of Health Regulation, established by Decree No. 25-2006 amending and supplementing Decree No. 71-98, Regulations to Law No. 290, Law on the Organization, Competence and Procedures of the Executive, published in Official Journal, La Gaceta, Nos 91 and 92 of 11 and 12 May 2006, which currently operates as the Directorate-General of Health Regulation in accordance with the institutional organizational chart. This entity will be known by the acronym ANRS and will be domiciled in the city of Managua. The purpose of the ANRS will be to facilitate, regulate, implement, develop and coordinate policies, laws, regulations and standards concerning health authorizations, surveillance, promotion, advertising, control and inspection of: medicines (breast milk and breast milk substitutes), vaccines, biological and biotechnological products; natural homeopathic and medicinal products; food and beverages; nutritional supplements; medical devices and other health-related technology; all products relating to ionizing radiation; precursor chemicals; cosmetic and hygiene products; and tobacco and tobacco products. Its purpose will also be to: regulate and control donations, foreign medical brigades, medical and non-medical inputs; and regulate health professional practices, audits on the quality of health care services, establishments providing health services, pharmaceutical and non-pharmaceutical establishments, food establishments, and establishments providing disinfection, structural or housing sanitation services using pesticides, toxic, hazardous and other similar substances; and others that may have an impact on health.

Products Covered: (HS code(s): 04, 09, 10, 11, 12, 15, 16, 17, 18, 19, 20, 21, 22, 24, 30); (ICS code(s): 11.100.01, 11.120.01, 11.120.10, 11.140, 13.280, 65.160, 67.020, 67.040, 67.060, 67.100, 67.140, 67.160, 67.180, 67.190, 67.200, 67.220, 67.230, 67.250, 67.260)

Regulation Type: Regular notification

Distribution date: 28 June 2021

The notified Andean Technical Regulation on Good Manufacturing Practices (GMP) for Cosmetic Products was approved pursuant to Andean Community Resolution No. 2206. The notified Andean Technical Regulation seeks to establish GMP requirements to be met by enterprises and establishments that manufacture, package, arrange and assemble cosmetic products marketed in the territories of the Andean Community member countries. __________

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 28 June 2021 | Final date for Comment: 27 August 2021

This regulation specifies the following:Terms and Definitions, Scope, Objectives, Supplier Obligations, Labelling, Conformity Assessment Procedures, Responsibilities of Regulatory Authorities, Responsibilities of Market Surveillance Authorities, Violations and Penalties, General Provisions, Transitional Provisions, Appendix (lists, types, safety and health requirements)

Products Covered: 3505 3506 3919 4811 5906

Regulation Type: Regular notification

Distribution date: 28 June 2021

The notified Andean Technical Regulation on Good Manufacturing Practices (GMP) for Cosmetic Products was approved pursuant to Andean Community Resolution No. 2206. The notified Andean Technical Regulation seeks to establish GMP requirements to be met by enterprises and establishments that manufacture, package, arrange and assemble cosmetic products marketed in the territories of the Andean Community member countries. __________

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 28 June 2021

The notified Andean Technical Regulation on Good Manufacturing Practices (GMP) for Cosmetic Products was approved pursuant to Andean Community Resolution No. 2206. The notified Andean Technical Regulation seeks to establish GMP requirements to be met by enterprises and establishments that manufacture, package, arrange and assemble cosmetic products marketed in the territories of the Andean Community member countries. __________

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 28 June 2021

The notified Andean Technical Regulation on Good Manufacturing Practices (GMP) for Cosmetic Products was approved pursuant to Andean Community Resolution No. 2206. The notified Andean Technical Regulation seeks to establish GMP requirements to be met by enterprises and establishments that manufacture, package, arrange and assemble cosmetic products marketed in the territories of the Andean Community member countries. __________

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 28 June 2021

The Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor) introduced a temporary restriction on imports of feed and feed additives used for animal feeding, including feed of plant origin, or containing products of chemical and microbiological synthesis from Estonia to the Russian Federation due to detection of numerous violations of EAEU SPS requirements.

Products Covered: Feed and feed additives used for animal feeding, including feed of plant origin, or containing products of chemical and microbiological synthesis (HS Codes: 0106, 0307, 0505, 0511, 1001, 1002, 1003, 1004, 1005, 1103, 1201, 1208, 1211, 1213, 1214, 1501, 1502, 1504, 1505, 1506, 1516, 1518, 2102, 2301, 2302, 2303, 2304, 2306, 2308, 2309)

Regulation Type: Emergency notifications (SPS)