Regulatory Updates
Scientific criteria for the determination of endocrine disrupting properties for plant protection products
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.
Products Covered:
Regulation Type: Addendum to Regular Notification
Proposed measures to manage myrtle rust spores in Myrtaceae seed lots
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
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:
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)
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
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)
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
Draft revision of the Ordinance on Licensing in the Medicinal Products Sector, 41 pages, available in German, French and Italian.
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
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
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
TITLE: Labeling of Certain Household Products Containing Methylene Chloride; Supplemental Guidance; Correction AGENCY: Consumer Product Safety Commission ACTION: Guidance; correction SUMMARY: The Consumer Product Safety Commission is correcting supplemental guidance on the Labeling of Certain Household Products Containing Methylene Chloride, which appeared in the Federal Register of 21 March 2018. The document provides guidance regarding labeling to warn of acute hazards associated with paint strippers containing methylene chloride. This correction provides the appropriate link to the petition briefing package and the format of a warning label. DATES: This correction is effective 26 April 2018. As established in the supplemental guidance, the guidance document became applicable on the date of its publication in the Federal Register, 21 March 2018.
Distribution date: 30 April 2018
Products Covered: Household products containing Methylene Chloride
Regulation Type: Corrigendum to Regular Notification
Revocation of designation of Efrotomycin as feed additives
Distribution date: 27 April 2018 | Final date for Comment: 26 June 2018
The Ministry of Agriculture, Forestry and Fisheries (MAFF) will revoke designation of efrotomycin as feed additive since efrotomycin is no longer used, produced, imported or expected to be used in the future in/into Japan.
Products Covered: Efrotomycin as a feed additive
Regulation Type: Regular notification
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