Regulatory Updates

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

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Distribution date: 24 May 2018 | Final date for Comment: 23 July 2018

Proposed maximum residue limits (MRLs) for the following agricultural chemical. Pesticide: Acephate

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09);- Dairy produce, birds' eggs (HS Codes: 04.01, 04.07 and 04.08);- Products of animal origin (HS Codes: 05.04);- Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14);- Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.05, 08.06, 08.07, 08.10, 08.11 and 08.14);- Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10);- Cereals (HS Codes: 10.05 and 10.06);- Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.07 and 12.12);- Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06).

Regulation Type: Regular notification

Food safety Maximum residue limits (MRLs) Human health Pesticides

The draft of a Government decision approving the models of certain acts

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Distribution date: 22 May 2018 | Final date for Comment: 21 July 2018

This draft decision establishes clear and transparent models of acts necessary for the importation, storage and  production of plant protection products (pesticides, agri chemicals) and fertilizers. It provides simple models for the following acts:1. model of the notification about the importation of plant protection products and fertilizers;2. model of the notification about the manufacture of plant protection products and/or fertilizer;3. model of the notification concerning the request for validation and registration of specialized deposits for storing plant protection products and/or fertilizers;4. plant passport model.

Products Covered: Plant protection products (pesticides) and fertilizers

Regulation Type: Regular notification

Food safety Human health Pesticides Plant health

Scientific criteria for the determination of endocrine disrupting properties for plant protection products

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Distribution date: 18 May 2018

On 15 June 2016 a draft legal act setting criteria to identify endocrine disruptors under the plant protection products regulation was issued by the European Commission (Commission). This proposal was notified in G/SPS/N/EU/166 on 20 June 2016. In December 2016, this draft legal act was split into two parts without any change in content: one text containing the criteria for identifying endocrine disruptors, and the other containing a proposed amendment to the derogation possibility based on negligible exposure. Information regarding developments in the legislative process was provided by the EU in G/SPS/GEN/1594 on 20 December 2017. The text containing the criteria for identifying endocrine disrupting properties for plant protection products was adopted as Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (Text with EEA relevance) [OJ L 101, 20 April 2018, p. 33]. On 2 May 2018 a Corrigendum – referring to the date of application – was published to Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties [OJ L 111, 2.5.2018, p. 10–10]. This Regulation shall apply from 10 November 2018.

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Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

Proposed measures to manage myrtle rust spores in Myrtaceae seed lots

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Distribution date: 16 May 2018 | Final date for Comment: 15 July 2018

MPI is proposing the following options for management of myrtle rust in Myrtaceae seed lots:  Seed sourced from a country free from Austropuccinia psidii (formerly Puccinia psidii or Uredo rangelii), orSeed must be treated with one of the approved chemical treatments as per MPI Standard MPI-STD-ATBRT Approved Biosecurity Treatments. MPI recommends one of the following fungicides: Azoxystrobin, Triadimenol, Mancozeb, Triforine and Tebuconazole at maximum label rate.

Products Covered: Myrtaceae seeds for sowing

Regulation Type: Regular notification

Seeds Pests Plant health

The Republic of Colombia hereby notifies that the draft amendment to Resolution No. 689 of 2016 of the Ministry of Health and Social Welfare and the Ministry of the Environment and Sustainable Development, "Adopting the Technical Regulation establishing the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps, and introducing other provisions", notified on 15 January 2018 by the World Trade Organization in document G/TBT/N/COL/214/Add.3, has been issued pursuant to Resolution No. 1770 of 4 May 2018. The aforementioned Resolution will enter into force as from its date of publication. It amends Articles 6, 7 and 12 of Resolution 689 of 2016 and repeals its technical annex. Text available online at: http://extranet.comunidadandina.org/SIRT/public/index.aspx Enquiry point: Contact person: María Leonisa Ortiz Bolivar. Email: mortizb@mincit.gov.co / mgonzalezs@mincit.gov.co Calle 28, N° 13A - 15, tercer piso Bogotá, D.C., Colombia Tel.: (+57-1) 606 7676, Ext. 1690/1340 Website: http://www.mincit.gov.co/publicaciones.php?id=33051 / http://www.sical.gov.co/reglamentos-tecnicos Also available at:

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Distribution date: 14 May 2018

Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 3405400000) ;

Regulation Type: Addendum to Regular Notification

Resolución Ejecutiva No. 001-2018 Regulación de ciertas sustancias prohibidas y restringidas de uso veterinario en la República de Nicaragua (Executive Resolution No. 001-2018 regulating certain prohibited and restricted substances for veterinary use in the Republic of Nicaragua)

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Distribution date: 03 May 2018

The notified Executive Resolution contains a list of substances for veterinary use and provisions regulating and controlling the use and marketing of such substances, based on their prohibited or restricted status. It contains provisions prohibiting, on national territory, the manufacturing, registration, importation, sale, marketing, transport, storage, handling, possession and use of the following substances, whether alone or combined, as raw materials or in finished veterinary drugs, and intended for any animal species and using any route of administration: Thyrostatics, carbadox, malachite green, olaquindox, nitrofurans, sulfathiazole, vancomycin, strychnine, organochlorides (chlorinated compounds), stilbenes, chloramphenicol and any of its salts, ethion, clenbuterol, gentian violet, dimetridazole, chlorpyrifos, avermectins, sulphonamides (sulpha drugs), antimicrobials to promote growth or improve yields, anabolics, beta-agonists, coccidiostats and coccidiocides.

Products Covered: Substances for veterinary use: Thyrostatics, carbadox, malachite green, olaquindox, nitrofurans, sulfathiazole, vancomycin, strychnine, organochlorides (chlorinated compounds), stilbenes, chloramphenicol and any of its salts, ethion, clenbuterol, gentian violet, dimetridazole, chlorpyrifos, avermectins, sulphonamides (sulpha drugs), antimicrobials to promote growth or improve yields, anabolics, beta-agonists, coccidiostats and coccidiocides.

Regulation Type: Regular notification

Veterinary drugs Human health Animal health Food safety

Reglamento de la Ley General de Salud en materia de Control Sanitario de la Cannabis y derivados de la misma (Implementing Regulations to the General Law on Health with respect to the sanitary control of cannabis and derivatives thereof)

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Distribution date: 03 May 2018 | Final date for Comment: 02 July 2018

The notified document contains regulations describing the pharmacological derivatives of cannabis and setting out the requirements governing their marketing for industrial use. It covers the following: sowing, cultivation, harvesting, preparation, consolidation, acquisition, possession, trade, any form of transportation, supply, employment, use, consumption, and in general, any activity relating to cannabis conducted for medical and scientific research purposes. The Regulations are binding throughout national territory.

Products Covered: Cannabis sativa, indica and americana or marijuana, resin, preparations, seed, pharmacological derivatives and products for extensive industrial use containing cannabis derivatives in a concentration equal to or less than 1% of Tetrahydrocannabinol (THC) (Tariff headings concerned: 13021902, 12099907, 12119002, 30034001, 30049033, 30039005, 30044002)

Regulation Type: Regular notification

Human health

Draft revision of the Ordinance on Licensing in the Medicinal Products Sector, 41 pages, available in German, French and Italian.

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Distribution date: 02 May 2018 | Final date for Comment: 01 July 2018

The Ordinance on Licensing in the Medicinal Products Sector (SR 812.212.1) is being currently revised due to numerous amendments relating to the ordinary revision of the Therapeutic Products Act (TPA) adopted by Parliament on 18 March 2016 as well as to the approval and implementation of the Medicrime Convention adopted by Parliament on 29 September 2017. The following amendments of the abovementioned ordinance may be relevant for international trade: more detailed specifications with regard to the licence for the import, export and foreign trade of medicinal products new licence for the activities of brokers simplifications with regard to the individual import of immunological medicinal products or blood/blood products new regulation concerning the import of unauthorised medicinal products in small quantities by private individuals and by health professionals

Products Covered: Medicinal products: products of chemical or biological origin which are intended to have or are presented as having a medicinal effect on the human or animal organism, in particular in the diagnosis, prevention or treatment of diseases, injuries and handicaps; blood and blood products are also considered to be medicinal products (relevant tariff items: 3002, 3003, 3004).

Regulation Type: Regular notification

Reglamento de la Ley General de Salud en materia de Control Sanitario de la Cannabis y derivados de la misma (Implementing Regulations to the General Law on Health with respect to the sanitary control of cannabis and derivatives thereof), 15 pages, in Spanish

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Distribution date: 01 May 2018

The notified document contains regulations describing the pharmacological derivatives of cannabis and setting out the requirements governing the marketing of cannabis for industrial use. It covers the following: sowing, cultivation, harvesting, preparation, consolidation, acquisition, possession, trade, any form of transportation, supply, employment, use, consumption, and in general, any cannabis-related activity conducted for medical and scientific research purposes. The Regulations are binding throughout national territory.

Products Covered: Cannabis sativa, indica and americana or marijuana, resin, preparations, seeds, pharmacological derivatives and products for extensive industrial use containing cannabis derivatives in a concentration equal to or less than 1% of Tetrahydrocannabinol (THC). (Tariff headings concerned: 13021902, 12099907, 12119002, 30034001, 30049033, 30039005, 30044002).

Regulation Type: Regular notification

Health measure on polymyxin E (colistin) and polymyxin B

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Distribution date: 30 April 2018

The Republic of Colombia hereby notifies that draft Colombian Agricultural Institute (ICA) Resolution "Prohibiting the importation, manufacturing, registration, marketing and use of additives containing polymyxin E (colistin) and polymyxin B as growth promoters for animals producing food for human consumption", notified on 20 November 2017 by the World Trade Organization in document G/SPS/N/COL/275, has been issued pursuant to ICA Resolution No. 00022747 of 9 April 2018, which will enter into force upon its publication in the Official Journal. Text available at: https://members.wto.org/crnattachments/2018/SPS/COL/18_2294_00_s.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

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