Distribution date: 06 March 2018 | Final date for Comment: 05 May 2018

The notified text establishes the health and safety requirements to be met by apiaries and by establishments where honey and apiculture products are processed for direct human consumption. Its aim is to protect consumer health via the inspection, approval and health certification of these products. Its provisions cover the health and safety requirements applicable to apiaries and beekeeping establishments, and touch upon inspection, approval, safety management system certification, traceability, and the national programme for the monitoring and control of chemical residues.

Products Covered: ICS number: 67.180.10 Honey and apiculture products

Regulation Type: Regular notification

Distribution date: 06 March 2018 | Final date for Comment: 27 May 2018

Este Proyecto revisión de Reglamento Técnico establece el Objeto; campo de aplicación; definiciones; requisitos; muestreo; ensayos para evaluar la conformidad; documentos de referencia; procedimiento para la evaluación de la conformidad; autoridad de vigilancia y control; régimen de sanciones; responsabilidad de los organismos de evaluación de la conformidad y revisión y actualización del Reglamento Técnico Ecuatoriano RTE INEN 088 (1R) "Agentes de tensión superficial".

Products Covered: (HS code(s): 340119, 340130, 340220, 340290, 340540); (ICS code(s): 71.100.40)

Regulation Type: Revision to Regular Notification

Distribution date: 08 March 2018 | Final date for Comment: 28 April 2025

This Resolution applies to requests for post-registration alteration of medicines and biological products filed with Anvisa before and after Law 13.411 of 28 December 2016. Art. 2. The maximum period for the final decision in the post-registration change processes of medicines and biological products will be, respectively: I - for the priority category, of sixty days, counted from the date of the respective prioritization protocol; II - for the ordinary category, one hundred and eighty days, counted from the date of the respective post-registration change protocol. Paragraph 1. The aforementioned period may be extended by up to one-third of the original term, once, by means of a reasoned decision of Anvisa issued at least fifteen business days before the end of the original term. Paragraph 2. The aforementioned period will have their countdown suspended when they request information or requirements, until they are attended to. Art. 6. Petitions for post-registration changes petitioned before the enactment of Law nº 13.411, of 2016, for which a safety and efficacy report is required, will have its analysis procedures maintained and can only be implemented after approval by Anvisa. Art. 8. The Anvisa areas responsible for medicine registration, inspection, monitoring and monitoring will establish a program to monitor post-registration changes implemented in accordance with the conditional approval set forth in this Resolution. Art. 9. During follow-up inspections or inspection actions, the company must provide all documentation related to the complete technical dossier, required by the health regulations in force at the time of the petition, which deals with post-registration changes. Art. 17. This Resolution comes into force on the date of its publication.

Products Covered: Chapter 30 - Pharmaceutical products

Regulation Type: Regular notification

Distribution date: 09 March 2018 | Final date for Comment: 08 May 2018

Some part of the measure notified as G/SPS/N/TPKM/448 on 22 November 2017, was promulgated on 7 March 2018, and will come into effect on 15 March 2018. Commodities classified under 22 specific CCC codes shall follow the "Regulations of Inspection of Imported Foods and Related Products" if they are used for food or food additives. The importers shall apply for inspection to the Food and Drug Administration, Ministry of Health and Welfare.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 13 March 2018 | Final date for Comment: 12 May 2018

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

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) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 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, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.04, 12.05, 12.06 and 12.07)- Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)                           

Regulation Type: Regular notification

Distribution date: 13 March 2018 | Final date for Comment: 12 April 2018

Regarding by-product fluid nitrogen fertilizers composed of fermented by-product, cultivation tests are not to be required for registration.

Products Covered: Fertilizer (HS: 3102, 3105)

Regulation Type: Regular notification

Distribution date: 15 March 2018 | Final date for Comment: 14 April 2018

Current fertilizer labelling forces operators to change labels on packaging materials even with a minor change in manufacturing process, leading to increase in production cost. To reduce the production cost, fertilizer labelling requirements are to be simplified.

Products Covered: Fertilizer (HS: 3101, 3102, 3103, 3104, 3105)

Regulation Type: Regular notification

Distribution date: 15 March 2018 | Final date for Comment: 14 April 2018

Current fertilizer labelling, forces operators to change labels on packaging materials even with a minor change in manufacturing process, leading to increase in production cost. To reduce the production cost, fertilizer labelling requirements are to be simplified.

Products Covered: Fertilizer (HS: 3101, 3102, 3103, 3104, 3105)

Regulation Type: Regular notification

Distribution date: 15 March 2018 | Final date for Comment: 14 April 2018

Zeoliteis to be newly added to the list of anti-caking material available for designated compounded fertilizers.

Products Covered: Fertilizer (HS: 3101, 3102, 3104, 3105)

Regulation Type: Regular notification

Distribution date: 15 March 2018 | Final date for Comment: 14 May 2018

This draft Commission delegated regulation amends certain requirements related to the labelling of olive oil. In particular, it provides clarification in respect of certain optional indications (values of certain physico-chemical parameters that have to be labelled when the acidity is mentioned; harvesting year). It also clarifies the mention of the harvesting year and introduces a possibility for the EU Member States to make the labelling of the harvesting year compulsory for extra virgin and virgin olive oil, for the domestic production only (*), and as long as other requirements set out in Regulation (EU) No 29/2012 are fulfilled (i.e. that all the olive oil in the container comes from that harvest). (*) This obligation is limited to olive oil obtained from olives harvested domestically and intended for their national markets only.

Products Covered: HS codes: 15.09.10 virgin olive oil, 15.09.90 olive oil not chemically modified other than virgin, 15.10.00 other oils obtained solely from olives (crude or refined olive-pomace oil and its blends with virgin olive oils)

Regulation Type: Regular notification