12 January - 20 June 2016

Legislation headlines

  • Placing on the market products containing, consisting of, or produced from genetically modified maize
  • Review for list entry Eleutherococcus senticosus – list of herbal substances
  • Adding species of Melaleuca to the list of herbal substances
  • Entering a name in the register of protected geographical indications (Sicilia (PGI))
  • Scientific opinions

Placing on the market products containing, consisting of, or produced from genetically modified maize
On 9 February 2009, Syngenta France SAS submitted to the competent authority of Germany an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from Bt11 × MIR162 × MIR604 × GA21 maize. The application also covers the placing on the market of genetically modified maize Bt11 × MIR162 × MIR604 × GA21 in products consisting of it or containing it for other uses than food and feed as any other maize, with the exception of cultivation.   On 5 July 2013, Syngenta extended the scope of the application to all sub-combinations of the single genetic modification events constituting Bt11 × MIR162 × MIR604 × GA21 maize (‘sub-combinations’), including Bt11 × GA21 maize, MIR604 × GA21 maize, Bt11 × MIR604 maize, and Bt11 × MIR604 × GA21 which are already authorised respectively by Commission Decisions 2010/426/EU (3), 2011/892/EU (4), 2011/893/EU (5) and 2011/894/EU (6). Syngenta asked the Commission to repeal those four Decisions once authorisation is given to Bt11 × MIR162 × MIR604 × GA21 maize and all sub-combinations.  On 7 December 2015, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (7). It concluded that genetically modified maize Bt11 × MIR162 × MIR604 × GA21, as described in the application, is as safe and as nutritious as its conventional counterpart and no safety concerns are identified for any of the sub-combinations.

Review for list entry Eleutherococcus senticosus – list of herbal substances
In 2008 an opinion of the European Medicines Agency established that Eleutherococcus senticosus (Rupr. et Maxim) Maxim complied with the requirements set out in Directive 2001/83/EC as a herbal substance, a herbal preparation or a combination and it was therefore included in the list of herbal substances, preparations and combinations for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC.  The Committee for Herbal Medicinal Products has reviewed the list entry Eleutherococcus senticosus (Rupr. et Maxim) Maxim and adopted an opinion to change the list entry with regard to the name of the herbal substance in certain EU official languages, the phrasing of the herbal preparations, update of the reference to the European Pharmacopoeia and update of some information necessary for the safe use.

Adding species of Melaleuca to the list of herbal substances
Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum can be considered as a herbal substance, a herbal preparation or a combination.  It is therefore appropriate to include Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and other species of Melaleuca, aetheroleum in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC.

Entering a name in the register of protected geographical indications (Sicilia (PGI))
Italy's application to register the name ‘Sicilia’ was published in the Official Journal of the European Union. As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Sicilia’ should therefore be entered in the register.

Scientific opinions

Re-evaluation of titanium dioxide (E 171) as a food additive

Safety and efficacy of Lavipan® (Lactococcus lactis B/00039, Carnobacterium divergens KKP 2012p, Lactobacillus casei B/00080, Lactobacillus plantarum B/00081 and Saccharomyces cerevisiae KKP 2059p) for weaned piglets, chickens for fattening and turkeys

Setting of import tolerance for flutriafol in cucurbits with edible peel

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