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In the European Union, genetically modified organisms (GMOs) need to undergo an authorisation procedure in which an environmental risk assessment (ERA) is performed in order to conclude on potential risks to the environment.
(8) Authorisation for both national and international regular services should be subject to an authorisation procedure.
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He said payments were "subject to a strict authorisation procedure and are limited".
The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes.
The EU has recently adopted new regulations, which establish a common authorisation procedure for food additives and, for the first time, food enzymes and flavouring agents.
Recently in the EU, a new regulation was issued for flavouring substances under Regulation (EC) No. 1334/2008 and a new authorisation procedure under Regulation (EC) No. 1331/2008 was adopted (as discussed above in "Direct food additives").
The continuity of the scientific aspects is assured by the requirement that 5 member of the PDCO are also members of the Committee for Human Medicinal Product CHMPP) the opinion taking body in a marketing authorisation procedure for medicinal products.
Recently in the EU, a new regulation was issued for enzymes under Regulation (EC) No. 1332/2008 and a new authorisation procedure under Regulation (EC) No. 1331/2008 was adopted (as discussed above).
In order to increase consistency in common areas of the procedural aspects of food additives' approval, guidelines for evaluation by EFSA and decision-making by the Commission, are provided in Regulation (EC) No. 1331/2008 (adopted 16 December 2010) which establishes a common authorisation procedure for food additives, food enzymes and food flavourings.
Draft plans to encourage food innovation via a new, simplified authorisation procedure for novel foods, already informally agreed with the Council of Ministers, were endorsed by the Environment Committee on Thursday.
The European Food Safety Authority EFSAandand its GMO Panel play a crucial role in this authorisation procedure as they issue, based on data provided in the GMO applications, scientific opinions on the safety of GMOs and provide advice for risk managers (i.e. the European Commission and the EU Member States).
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