75 -Non GMO or GMO-free labelling or advertisement of foods that are not subject to GM labelling is prohibited in order to prevent consumers’ misunderstanding and confusion. Objeto y razón de ser: Consumer information, consumer choice, food labelling. Notificación: G/TBT/N/KOR/642 Regulation for the Labelling of Livestock Products (63 pages, in English). The regulation for the labelling of livestock products has been revised in order to simplify the labelling method and prevent obligators’ confusion. 1. Introduces mandatory labelling of meat content in meat processing products (ham, sausage etc.) 2. Clarifies labelling method of frozen and refrigerated pro-ducts: • Introduces mandatory labelling of frozen product or refri-gerated product on principal display panel 3. Introduces exceptional clauses for labelling requirements: • The product which is supplied to a member store, not final consumer, could indicate necessary labelling information 4. Adjusts standards to harmonize with the labelling stan-dards for foods: • Integrate general display panel and other display panels into information display panel, and newly suggest stan-dards for principal display panel and information display panel • Require the use a font size of 10 or greater when displa-ying labelling information • Allow to use weight or volume regardless of the characte-ristics of net contents if solid or liquid • For the Korean labelling of imported livestock, allow the labelling according to Korean orthography principles of foreign languages. Objeto y razón de ser: Protection of consumers and promotion of public health. Notificación: G/TBT/N/KOR/647 Proposed amendments to the Pharmaceutical Affairs Act (65 pages, in Korean) • To establish a legal basis to register foreign drug manufac-turing plants and perform foreign inspections • A penalty shall be imposed on a manufacturer/importer of substandard/spurious/falsely labelled/falsified/counterfeit medical products. The amount of penalty surcharge shall not exceed 5% of total amount of production/imports in the previous year. • The head of a clinical trial institution may ask the com-missioner of the Ministry of Food and Drug Safety for the assessment of safety and efficacy of off – label uses. • The name of all quasi – drugs should be specified. And if the information on the container or the packaging of the quasi – drug is physically unreadable due to being covered by ex-ternal containers or packaging, the same information should also be indicated on the external containers or packaging. Objeto y razón de ser: • To strengthen safety control of foreign drugs by establishing a legal basis for foreign inspections of pharmaceutical manufacturing plants • To improve public health and actual effectiveness of admi-nistrative disposition by imposing a penalty surcharge on a manufacturer/importer of SSFFC, not exceeding 5% of total amount of production/imports in the previous year • To evaluate the safety and efficacy of drugs for off label use in a systemic and comprehensive way and enhance its follow – up management • To provide accurate information on quasi – drugs to protect consumers UNIÓN EUROPEA Notificación: G/TBT/N/EU/375 Draft Commission Regulation amending Annex XVII to Regu-lation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Autho-risation and Restriction of Chemicals (REACH) as regards bis (pentabromophenyl)ether (5 pages + Annex 2 pages, in English) This notified draft relates to a new entry in Annex XVII to Regulation (EC) No 1907/2006. It intends to restrict the manufacturing and placing on the market of bis(pentabromophenyl)ether (decaBDE) as a subs-tance on its own and the use and placing on the market of decaBDE as a constituent of other substances, in mixtures, or in articles or any part thereof, in a concentration equal to or greater than 0,1% by weight. Exemptions are proposed for the production and placing on the market of aircraft; for the production and placing on the market of spare parts for aircraft, motor vehicles within the scope of Directive 2007/46/EC, agricultural and forestry ve-hicles within the scope of Regulation (EU) No 167/2013 and machinery within the scope of Directive 2006/42/EC; articles placed on the market for the first time before the date of application of the Regulation; and electrical and electronic equipment within the scope of Directive 2011/65/EC. Application of the restriction is deferred for 18 months to allow industry sufficient time to adapt and achieve com-pliance. Objeto y razón de ser: decaBDE is widely used as a flame retar-dant in particular in textiles and plastics. The persistent and bioccumulative properties of decaBDE give rise to specific concerns about its widespread distribution and potential to cause irreversible long-term harm to the environment, even after emissions have ceased. The toxicity of decaBDE has been determined based on the toxicity of its breakdown products. In addition, exposure to decaBDE in its lower bro-minated transformation products may result in neurotoxicity in mammals, including humans. The proposed restriction is expected to reduce emissions of decaBDE in the medium to long term and no significant costs to producers and downstream users are expected, taking into account the proposed exemptions.
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