82 Notificaciones OMC 3) (3) Any food product contains either (1) or (2) as an ingredient. However, food additives and food obtained through certain techniques of Genetic Modification/Genetic Engineering are not included in this notification. • Clause 2 – Novel food shall be evaluated on safety assessment prior to submit its label to Food and Drug Administration for approval before use. • Clause 3 – To evaluate safety assessment of such novel food, results of safety assessment by risk assessment centres recognized by Food and Drug Administration together with other relevant information described in the annex of this notification shall be submitted to Food and Drug Administration. Information and scientific data about novel food required in Annex covers general information, specification, history of use, production process, analytical method, recommended dose or instruction for use, toxicological information consisting of absorption, distribution, metabolism, and elimination (ADME) and toxicological studies in animal and/or human, and nutrition information. • Clause 4 – Novel food shall have specification and condition of use as approved by Food and Drug Administration. • Clause 5 – Producers or Importers of novel food shall follow this notification, a particular notification and relevant regulations with such novel foods. • Clause 6 – Labeling of novel food shall comply with the notification of MOPH (No.367) B.E. 2557 (2014) Re: Labeling of Prepackaged Foods, except clause 4(9) shall display date, month, and year of production and date, month, and year of expiration for consumption by expressing date, month, year respectively, and shall incorporated with declarations of “Produce”, “Expire”, or “Consume before”, as the case may be. In addition,the following information shall be expressed on its label; 1) Name of active ingredient (if any), and 2) Instruction of use, or condition of use such as type or category of food and maximum permitted level of use. • Clause 7 – This notification does not apply to novel food for exportation • Clause 8 – This notification does not apply to producers or importers of novel foods which are permitted and produced or imported prior to the date of this notification come into force. • Clause 9 – This notification shall come into force as from the day following date of its publication in the Government Gazette. Objeto y razón de ser: Consumer protection UNIÓN EUROPEA Notificación: G/TBT/N/EU/346 Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance amitrole, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Implementing Regulation (EU) No 540/2011 (4 pages, in English). This draft Commission Implementing Regulation provides that the approval of the active substance amitrole is not renewed in accordance with Regulation (EC) No 1107/2009. Existing authorised plant protection products containing amitrole will be withdrawn from the market. The non-approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly approved under Directive 91/414/ EEC. This decision only concerns the placing on the market of this substance and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. However, following non-approval, separate action will be taken to lower MRLs to the limit of quantification (LOQ). Objeto y razón de ser: Protection of human health or safety; protection of animal or plant life or health; protection of the environment. In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II) which must be met to enable approval. These concerns mean that amitrole does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently. Notificación: G/TBT/N/EU/354 Draft Commission Implementing Regulation concerning the non-renewal of approval of the active substance triasulfuron, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Implementing Regulation (EU) No 540/2011 (4 pages, in English). This draft Commission Implementing Regulation provides that the approval of the active substance triasulfuron is not renewed in accordance with Regulation (EC) No 1107/2009. Existing authorised plant protection products containing triasulfuron will be withdrawn from the market. The nonapproval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly approved under Directive 91/414/ EEC. This decision only concerns the placing on the market of this substance and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. However, following non-approval, separate action will be taken to lower MRLs to the limit of quantification (LOQ). Objeto y razón de ser: In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II) which must be met to enable approval.
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