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while Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients,290 specifically refers to foods and food ingredients consisting of or isolated from microorganisms or algae it also applies to a range of other novel foods and ingredients. In other words the fact Blue Biotechnology products are sourced from marine genetic resources does not matter: they are treated the same as other products including other types of biotechnology products. The same observation applies to the legislation applicable to pharmaceutical products291and cosmetic products292. Similar observations apply if Blue Biotechnology products are classified as genetically modified organisms (GMOs): the same regulatory framework applies as regards their deliberate release to the environment and/or placing on the market as for other types of biotechnology products.293 In terms of manufacturing too Blue Biotechnology products are subject to the same restrictions on emissions and environmental standards as other types of product.294 Liability A feature of the Blue Biotechnology sector is that it pertains not only to products based on genetic materials sourced from the marine environment but also on products that are used in the marine environment. This raises a final issue in terms of potential accidental harm caused by such products at sea in terms for example of the deliberate release of GMOs for such purposes as pollution abatement and anti-fouling. Article 196 imposes a duty on States ‘to prevent, reduce and control pollution of the marine environment resulting from the use of technologies under their jurisdiction or control, or the intentional or accidental introduction of species, alien or new, to a particular part of the marine environment, which may cause significant and harmful changes thereto’. The wording of this article would seem to be potentially broad enough to include GMOs if these are classified as a technology. However the fact remains that marine biotechnology was not considered during the development of UNCLOS. At the international level the issue of liability for damage caused by GMOs was addressed in 2000 in the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the ‘Cartagena Protocol’). The Protocol applies to the ‘transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health’.295 However, while the Cartagena Protocol and the subsequent Nagoya – Kuala Lumpur Supplementary Protocol On Liability And Redress To The Cartagena Protocol On Biosafety296 movements, both intentional and unintentional, as well as on liability for resulting environmental harm, their overall focus would appear to be on terrestrial boundaries and it is not entirely clear how they would apply to eventual harm caused by the deliberate release of GMOs to the sea. apply to transboundary 290 (OJ L 43, 14.2.1997, p. 1) 291 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1); Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 292 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). 293 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17/04/2001, p. 1). 295 Article 4. 296 16 October 2010. 294 In terms for example of Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) ( OJ L 334, 17.12.2010, p. 17). Study in support of Impact Assessment work on Blue Biotechnology 209

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