See question 13 for further detail.

The Swedish Environmental Code, 13th Chapter provides the regulations for genetically modified organisms for contained use and deliberate release of GMOs into the environment, as well as products containing or consisting of such organisms on the market. In addition, the EU regulations and directives are to be applied and enforced in Swedish regulations and guidelines on genetically modified organisms. EU legislation on GMOs has been in place since the early 1990s. The EU introduced specific legislation on GMOs to protect citizens' health and the environment while simultaneously creating a unified market for biotechnology development, use and transfer of GMOs. The main pieces of legislation are: - Directive2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, covering the field testing of GMOs and the placing on the market of GMOs as well as products containing or consisting of GMOs, e.g. for cultivation, import or processing into industrial products. - Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed, covering the placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs. -Regulation (EC) No 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms. - Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms covers exports of GMOs to third countries and unintentional movements of GMOs. -Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation. - Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms. - Commission Regulation 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired. - Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC)No 641/2004 and (EC) No 1981/2006. More information on the content of these legislative acts is available at: http://ec.europa.eu/food/plant/gmo/new/legislation/index_en.htm In the case of Directives 2001/18/EC and (EU) 2015/412, and of Regulations (EC) No 1829/2003, 1830/2003 and 1946/2003, Member States have introduced domestic provisions to ensure enforcement and/or transposition of this legislation within their territories.

The Swedish Pharmaceutical Law (SFS 2015:13) and Pharmaceutical Regulation (SFS2015:458) covers all pharmaceuticals including those that contain genetically modified organisms, but no specific mention is made to GMO. EU pharma legislation provides that a medicinal product may only be placed on the market in the EU if it has received marketing authorisation, granted either by the European Commission or by a member state. As regards medicinal products containing or consisting of GMOs, the assessment for a marketing authorisation must include an environmental risk assessment in line with the requirements of Directive 2001/18/EC. Regulation 1946/2003, which mirrors the provisions of the Protocol regarding exports of pharmaceuticals.

Sweden follows Regulation (EC) No 1946/2003 addressing the transboundary movement of GMOs and aiming to ensure coherent implementation of the provisions of the Cartagena Protocol in the EU. It establishes rules for the transit of GMOs and for the transboundary movement of GMOs intended for contained use, in line with the provisions of the Cartagena Protocol. LMO’s in Contained use: The Swedish Environmental Code 13th Chapter §8-10 regulate contained use of genetically modified organisms. Swedish Regulation (200:271) on contained use of genetically modified organisms provides more detailed specified regulations on contained use. The Swedish Work Environment Authority is the designated competent authority for contained use. Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organism. Transit of LMO: According to Article 13 of Regulation (EC) No 1946/2003, the exporter shall ensure notification of the transit of GMOs to Parties that have taken the decision to regulate transit of GMOs through their territory and have informed the BCH of this decision. Finally, transit procedures through the EU are regulated by the EU transport legislation and the Customs Code.

As also detailed in the 5th National Report of the European Union, the EU applies its domestic legislative framework instead of the Protocol's advanced informed agreement procedure. This domestic framework is in line with the provisions of the Protocol. The EU domestic legislative framework is built on a range of legislative measures described above in this report. Release on the market Article 7 – 10 for release on the market is implemented in legislation at the EU level (Dir. 2001/18, Reg, 1829/2003 and Reg. 1830/2003). A developer intending to market a GMO in the EU for intentional introduction into the environment must first obtain an authorisation to this end. The authorisation procedure for placing the GMO on the market involves all Member States, as authorised products are granted free movement throughout the territory of the EU. The so-called "notification" or "application" submitted by the interested developer must include a full evaluation of potential risks to human and animal health and to the environment. It is only after a decision for authorisation is finally adopted based on a prior risk assessment that the developer can proceed with the marketing of the GMO in the EU. 32 - 33. The European authorisation process for release on the market of an LMO (Dir. 2001/18) includes a provision that the competent authority that first receives a notification shall also write the decision. This has been done only once by a Swedish authority, in 2010. The authorisation is applicable throughout all of the European community. Release to the Environment Decisions on intentional introduction to the environment as field trials ar made at the national level. The Swedish Environmental Code 13th Chapter lays down the regulations for intentional release of genetically modified organisms to the environment. The EU Directive 2001/18/EC is implemented through the Swedish Ordinance (2002:1086) on release of genetically modified organisms to the environment, all in compliance with the provisions of the Cartagena Protocol. Import - The regulation for authorisation of an LMO is based on the use of the LMO, not the transboundary movement in itself - though import might be one of the areas of use. Decisions on field trials are always based on an application that corresponds with the provisions of the Protocol’s articles 7 - 10 and 12. Permission must be given by the competent authority before a release into the environment – regardless of whether the LMO is produced within the country or imported. Export - According to EU legislation, the export of GMOs is primarily an issue between the exporter and the Party of import. Swedish authorities are responsible for supervising an exporter’s compliance with the rules i.e. Regulation (EU) 1946/2003. Regarding exports, the EU legislation (Reg. no 1946/2003) does not specifically address the accuracy of the information provided by the exporter. But the penalties laid down in the Swedish Environmental Code Chapter 29, Section 9.7 -9.8 lay down the penalty for violation of articles 6, 12 and 13 of Reg. (EU) 1946/2003.

The Swedish Environmental Code 13th Chapter on Genetic Engineering is also applicable to products containing or consisting of genetically modifed organisms to be placed on the market. Cartagena Protocol’s art 11 is implemented in legislation at the EU level. The EU has developed a comprehensive legal framework on GMOs, that also addresses the import of GMOs intended for direct use for food or feed, or for processing. The EU has declared with reference to Article 14.4 of the Cartagena Protocol that it relies on its existing legislative framework for intentional movements of GMOs within the EU and for imports of GMOs into the EU. With regard to the decisions on placing GMOs on the market for direct use as food or feed, it should to be noted that these are taken for the entire European territory and not by Sweden och another Member State individually. We also refer to the EU’s Fifth National Report for more information.

Article 12 is implemented in legislation at EU level through article 20 of Directive 2001/18 and articles 21 and 22 of Regulation 1829/2003.

Article 12 is implemented in legislation at EU level through article 20 of Directive 2001/18 and articles 21 and 22 of Regulation 1829/2003.

The EU has not entered into any bilateral, regional or multilateral agreements or arrangements as per Article 14(1). The EU has determined as per Article 14(4) and 9 (2)(c) that it relies on its existing legislative framework for intentional movements of GMOs within the European Union and for imports of GMOs into the European Union. This decision has been communicated to other Parties through the Biosafety Clearing-House.

72. Please use the space below to provide further details on the implementation of Articles 15 and 16 in your country: Risk assessments for field trials are assessed by competent authorities in Sweden according to national legislation in the Swedish Environmental Code 13th Chapter Sections 8-9, 12-14, as well as the Swedish Regulation (SFS 2002:1086) in line with EU legislation. EU and national legislation require the notifier to perform a risk assessment according to guidance developed by the European Food Safety Agency (EFSA), when applying for approval of an LMO for cultivation or as food or feed. (EU regulation 1829/2003 and 2001:18.) The Swedish Environmental Protection Agency makes use of the Guidance on Risk Assessment of LMOs as reference material in addition to the EFSA guidance on risk assessment when evaluating risk assessments submitted for approval for field trials. Risk assesments are evaluated by the competent authorities including the Swedish Board of Agriculture, the Environmental Protection Board and the Gene Technology Advisory Board. Organizations and members of the general public are invited to comment the applications which include risk assessments. EU regulations and EFSA guidelines on risk assessment of genetically modified plants and animals are harmonized and followed in decision-making in Sweden. The EU domestic legal framework on GMOs is based on a prior risk assessment before authorization can be given. The EU has put in place a comprehensive system of risk assessment and risk management of releases into the environment or placing on the market of GMOs, whether imported into or developed within the EU. The notification provided by the developer intending to market a GMO must include a full risk assessment of the risks to human and animal health and to the environment, which is assessed by the European Food Safety Authority (EFSA), with active involvement of Member States, notably as regards the authorization of GMOs for cultivation, where they carry out the initial risk assessment. The aim of the environmental risk assessment is, on a case-by-case basis, to identify and evaluate potential adverse effects of the GMO, both direct and indirect, immediate or delayed, on human health and the environment. See http://www.efsa.europa.eu/en/topics/topic/gmo. In accordance with the precautionary principle, environmental risk assessment must be based on the following principles: - GMO characteristics and GMO use that have the potential to cause adverse effects are to be compared to characteristics and use of the non-modified organism from which the GMO is derived; -Risk assessment should be carried out in a scientifically sound and transparent manner based on available scientific and technical data; - Risk assessment should be carried out on a case by case basis; - New information on the GMO and its effects may need to be assessed to determine whether the risk has changed and whether there is a need for amending the risk management accordingly. Article 4 of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms demands that any person submitting a notification under the authorisation procedures for GMO releases into the environment or placing on the market of GMOs as or in products needs to carry out an environmental risk assessment. Annex III of the Directive specifies the information that may be necessary to carry out the risk assessment. The environmental risk assessment is conducted for each relevant area of risk and comprises six steps: 1. Problem formulation including hazard identification, aimed at identifying: (i) changes in the characteristics of the organism, linked to the genetic modification, (ii) potential adverse effects on human health or the environment which are linked to these changes, (iii) relevant assessment endpoints, (iv) exposure pathways or other mechanisms through which adverse effects may occur, either directly or indirectly, (v) testable hypotheses, and relevant measurement endpoints, to allow, where possible, a quantitative evaluation of the potential adverse effect(s), (vi) possible uncertainties, including knowledge gaps and methodological limitations. 2. Hazard characterization aimed at evaluating the magnitude of each potential adverse effect, taking into account the receiving environment(s) into which the GMO is intended to be released and the scale and conditions of the release. 3. Exposure characterization aimed at evaluating the likelihood or probability of each identified potential adverse effect. 4. Risk characterization, by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect. Where relevant, the uncertainty foreach identified risk shall be described. 5. Risk management strategies, to be proposed where risks are identified that require, on the basis of their characterization, measures to manage them. The risk management strategies shall be described in terms of reducing the hazard or the exposure, or both, and shall be proportionate to the intended reduction of the risk, the scale and conditions of the release and the levels of uncertainty identified in the environmental risk assessment. 6. Overall risk evaluation and conclusions, providing a qualitative and, where possible, quantitative evaluation of the overall risk of the GMO taking into account the results of the risk characterization, the proposed risk management strategies and the associated levels of uncertainty. The overall risk evaluation and conclusions shall also propose specific requirements for the monitoring plan of the GMO and, where appropriate, the monitoring of the efficacy of the proposed risk management measures. Annex VII of the Directive provides guidance on the monitoring plan as part of the risk management strategy. More specific guidance notes are provided in Council Decision 2002/811/EC of 3 October 2002. The objective of the monitoring plan is to confirm that any assumption regarding the occurrence and impact of potential adverse effects of the GMO or its use in the risk assessment are correct, and to identify the occurrence of adverse effects of the GMO or its use which were not identified in the risk assessment. The design of the monitoring plan should, among others: - Be detailed on a case by case basis; - Take into account the characteristics of the GMO, its use and scale of use, and the range of relevant environmental conditions; - Incorporate general surveillance for unanticipated adverse effects; - Provide for case-specific monitoring for a sufficient time period to detect immediate and direct as well as, where appropriate, delayed and indirect effects which have been identified in risk assessment.; - Provide for the use of already established routine surveillance practices where appropriate.

Article 14 of EU Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures.

Placing a product containing or consisting of GMO on the market requires labelling the product according to the Swedish Environmental Code 13th Chapter §18 to enable identification. Transport of GMOs from cultivation or products thereof are regulated in the Swedish Regulation (2007:273) on precautionary measures with cultivation and transport of genetically modified organisms. The laboratory of the Swedish Food Agency is a member of the EU Network of Laboratories and works with sampling, analysis and identification of genetically modified organisms in products for food or feed. The EU regulations and guidelines for handling, transport and identification of living modified organisms are harmonised and apply in Sweden. We therefore reiterate the information submitted by the European Union in its Fourth National Report on the Implementation of the Cartegena Protocol on Biosafety as follows. The EU has set up a comprehensive legal framework which addresses the topic of handling, transport, packaging and identification of living modified organisms (art. 18 of Cartagena Protocol): - Regulation(EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed; Implementing Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003; Implementing Regulation (EU) No503/2013 of 3 April 2013 on applications for authorization of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006. -Regulation (EC) No 1830/2003concerning the traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs; - Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms; - Regulation (EC) No 65/2004 of 14January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms - Directive 2008/68/EC of 24 September2008 on the inland transport of dangerous goods. - Commission Regulation 619/2011 of24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorization procedure is pending or the authorization of which has expired. As regards Article 18(1)of Cartagena Protocol, the existing EU legislation, Directive 2008/68/EC contains appropriate rules on the safe transport, handling and packaging. As regards Article18(2)(a) of Cartagena Protocol: - Regulation (EC) No 1829/2003 lays down rules on labelling of all GM food and feed. GM food and feed has to be labelled as GM, except if they contain GM material in a proportion no higher than 0.9% and if this presence is adventitious or technically unavoidable. - Regulation (EC) No 1830/2003 provides that business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of the placing on the market. In particular, the Regulation requires that: -- Operators are to have systems and standardized procedure sin place to identify to whom and from whom products are made available; -- At the first stage of the placing on the market of a product consisting of or containing GMOs, including bulk quantities, operators shall ensure that the following information is transmitted in writing to the operator receiving the product: (a) that it contains or consists of GMOs; (b) the unique identifier(s) assigned to those GMOs; and -- in the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed or for processing, written information on the unique identifier(s) assigned to the GMOs of which the product consists or which are contained in it, may be replaced by a declaration of use by the operator, accompanied by a list of the unique identifiers for all those GMOs that have been used to constitute the mixture. - Regulation (EC) No65/2004 established a system for the development and assignment of unique identifiers for genetically modified organisms. - Regulation (EC) No 1946/2003, under Article 12, provides that exporters are required to state in a document accompanying the GMO, which is to be transmitted to the importer receiving the GMO: -- that it contains or consists of GMOs; and -- the unique identification code(s) assigned to those GMOs if such codes exist. Article 12 further stipulates that for GMOs intended for direct use as food or feed, or for processing, the above information must be supplemented by a declaration by the exporter: -- stating that the GMOs are intended for direct use as food or feed, or for processing and indicating clearly that they are not intended for deliberate release into the environment; and -- giving details of the contact point for further information. In the case of products consisting of or containing mixtures of GMOs to be used only and directly as food or feed, or for processing, the above identification requirements may be replaced by a list of unique identifiers used to constitute the mixture. In relation to Article 18(2)(b) of Cartagena Protocol, the EU legislation contains rules on identification of GMOs that are destined for contained use, in line with the Protocol: - Regulation (EC) No 1946/2003, under Article 12, provides that exporters are required to state in a document accompanying the GMO, which is to be transmitted to he importer receiving the GMO: -- that it contains or consists of GMOs; and – the unique identification code(s) assigned to those GMOs if such codes exist. Article 12further stipulates that for GMOs intended for contained use, the information referred to in paragraph 1 shall be supplemented by a declaration by the exporter which shall specify: -- any requirements for the safe handling, storage, transport and use of these GMOs; -- the contact point for further information, including the name and address of the individual or institution to whom or which the GMOs are consigned. Finally, as regards Article 18(2)(c) of Cartagena Protocol, Regulation No (EC) 1946/2003 requires exporters of GMOs destined for deliberate release into the environment to ensure that documentation accompanying the GMO states: -- that it contains or consists of GMOs; and -- the unique identification code(s) assigned to those GMOs if such codes exist; In addition, this information shall be supplemented by a declaration by the exporter which shall specify: -- the identity and relevant traits and characteristics of the GMOs; -- any requirements for the safe handling, storage, transport and use of these GMOs; -- the contact points for further information and, as appropriate, the name and address of the importer and exporter; and -- a declaration that the movement is in conformity with the requirements of the Protocol applicable to the exporter. The above requirements regarding identification and documentation of GMOs are in line with Article 18 of the Protocol and without prejudice to further specific requirements imposed by EU legislation

The European Union has designated its own competent authority and focal point, while EU Member States have also designated their own national focal points and competent authorities. There is close collaboration and information sharing between EU and national administrations. Responsibility for administrating and handling living modified organisms in Sweden is shared by several central authorities, depending on the type of organism and its use. The Swedish Board of Agriculture is the competent authority for genetically modified plants and animals, excluding fish, and for use as feed. The Swedish Board of Food Safety is the competent authority for genetically modified food, the Swedish Work Environment Authority for contained use of genetically modified microorganisms, and the Swedish Marine and Water Management Agency for genetically modified fish the Swedish Medical Products Agency for pharmaceuticals containing or consisting of genetically modified organisms, the Swedish Board of Forestry for genetically modified trees and the Swedish Chemicals Agency for genetically modified microorganisms, nematodes, spiders and insects to be placed on the market. These authorities collaborate through a network that meets at least twice annually.

102 e – p. are not applicable as no such decisions have been made. On 102 q. We have updated some information on risk assessments of field trials to the BCH. The process is technically challenging and time-intensive. Information on risk assessments and decisions on field trials in Sweden may be available of the EU site of the BCH, as Swedish decisions are also reported to the EU GMO Registerhttps://gmoinfo.jrc.ec.europa.eu/, which in turn is reported by the EU to the BCH.

111. Please use the space below to provide further details on the implementation of Article 21 in your country: Article 25 in EU Directive 2001/18/EC and article 30 in EU Regulation 1829/2003 implement article 21 of the protocol. This is further implemented in the Swedish Public Access to Information and Secrecy Act 2009:400 and the Public access to information and secrecy ordinance 2009:641. Applications for field trials of living modified organisms, including risk assessments and decisions regarding the application are published and freely available on the website of the Swedish Board of Agriculture, with the exception of confidential material. The general public is invited to submit comments, which are then considered in the decision-making process. Regarding question 122. The notifier is allowed to identify what information it would like to be kept confidential according to national and EU regulations. The decision on whether theinformation is to be considered confidential is assessed by for the Swedish authority. However, certain information in an application must be public according to the regulations on public access to information and include; - A general description of the genetically modified organism, - Who is conducting the activity with the genetically modified risk and their address, - Information about the purpose of the activity, - Where the activity will occur - Risk classification - Protective measures - Plans for monitoring and contingency plans in emergency situations, - Risk assessments We also refer to the EU’s Fourth National Report on the Implementation of the Cartegena Protocol on Biosafety for more information on the EU regulations that apply. The EU applies its domestic legislative framework instead of the Protocol’s advance informed agreement procedure. This framework is compatible with the provisions of the Protocol. It contains confidentiality provisions that apply equally to domestic and foreign producers of GMO.

There have been no capacity-building activities at the EU and member state level as the Protocol is fully implemented. The EU and member states however contribute to capacity building initiatives and research in the field of biosafety for the effective implementation of the Protocol. Please refer to the EU Fifth National Report to the CartagenaProtocol on Biosafety for more information.

The Swedish Gene Technology Advisory Board through its website (www.genteknik.se) and other activities, disseminate information on GMO regulations, current research and carry out ethical review of applications and prepare government remits. The designated function of the Swedish Gene Technology Advisory Board is to promote, by means of consultation, uses of gene technology which are ethically defensible from the standpoint of human and animal health and the environment. That task includes dissemination of knowledge concerning the development of gene technology. The public should be informed in such a way that its interests in ethical and safety issues are safeguarded, while public debate and participation in such issues is stimulated. The responsible authorities in Sweden have information on their web sites for all notifications and applications for field trials. The public can read summaries of notifications and applications and is also given the opportunity to send in comments to the relevant national authorities. Depending on the scope of the application and what legislation it is notified within, the public can also submit comments via the European Union’s Joint Research Centre website, the EC commission or the competent authorities’ web-sites. The website of the Swedish Board of Agriculture (www.jordbruksverket.se)contains links to the EU Commission ́s registers approved for import, food and feed use and/or cultivation within the EU as well as decisions on field trials in Sweden. This information is also relayed to the EU Joint Research Centres GMO register and made freely available at https://gmoinfo.jrc.ec.europa.eu/ to the general public and other interested. In Sweden, the principle of public access to official documents is so important that it is regulated in the Swedish Constitution and in the Regulations on Public access and confidentiality (SFS 2009:400) and (SFS 2009: 400). Sweden is also a party to the Århus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters. All Swedish citizens are entitled to read documents held by public authorities. This means that documents received, as well as dispatched letters, decisions and reports, are in principle official, open documents and must be made available for anyone to read. Access to official documents may however be restricted if they are designated as confidential to protect specified interests. We also refer to the EU’s Fifth National Report on the Implementation of the Cartagena Protocol on Biosafety.

Please refer to the EU Fifth National Report on the Implementation of the Cartagena Protocol on Biosafety for more information.

According to Directive 2001/18/EC, it is the Member States that are obliged to take domestic measures to prevent and penalize illegal transboundary movements of GMOs. European legislation contains explicit obligations on Member States to lay down rules on penalties applicable to infringements of the provisions of European regulations. Infringement of EU Reg. no 1946/2003 will in Sweden be regarded as an infringement of the Environmental Code and the penalties laid down in the Code will apply. We also refer to the EU’s Fifth National Report on the Implementation of the Cartagena Protocol on Biosafety for more information.

The report “Possibilities to limit or forbid cultivation of genetically modified plants in Sweden” SOU 2016:22 was in response to the adoption of the European Union directive (EU) 2015:412 which allows – but does not require – Member States to limit or forbid cultivation on the basis of compelling grounds, which include socioeconomic impacts (see below for background information). The conclusion of the remit was a recommendation for Sweden to change the Environmental Code to allow limiting or forbidding cultivation of genetically modified organisms on the basis of “compelling grounds”. These “compelling grounds” could be environmental political or socioeconomic factors. However, these factors have not yet been defined. Cultivation is an issue with strong national, regional and local dimensions, given its link to land use, to local agricultural structures and to the protection or maintenance of local habitats, ecosystems and landscapes. In this respect, as set out in Directive (EU) 2015/412, a EU Member State may decide to restrict the cultivation of an authorised GMO, based on grounds related to environmental or agricultural policy objectives, or other compelling grounds including socioeconomic impacts, which might arise from the cultivation of the GMO on the territory of the Member State concerned. We also refer to the EU’s Fifth National Report on the Implementation of the Cartagena Protocol on Biosafety for more information on activities within the EU on Socio-economic considerations, in which Sweden has actively participated.

Routines exist for general participation, for instance authorities make information available on their websites and maintain mailing lists for sharing information and collecting comments. These processes are open to all private and public actors and thereby open to but not specific to indigenous peoples and local communities.

The requirements in the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress are addressed in the EU Directive 2004/35/EC on environmental liability (ELD) with regard to prevention and remedying of environmental damage. ELD has undergone an evaluation supported by an external study during the reporting period. (Please also refer to the EU’s Fifth National Report on the Implementation of the Cartagena Protocol on Biosafety for more information.) The Swedish Environmental Code 13th Chapter and Regulation (SFS 2004:667) on serious environmental damage provides the legal foundation for addressing environmental responsibility, liability and redress for genetically modified organisms as well as other activities in the environment.