EU legislation on genetically modified organisms (GMOs) has been in place since the early 1990s. The EU introduced specific legislation on GMOs to protect its citizens' health and the environment while simultaneously creating a unified market for biotechnology products. The EU has created a comprehensive legal framework for ensuring safety in the development, use and transfer of GMOs. The main pieces of legislation are:
- Directive 2001/18/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.
- Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015  amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory.
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. For implementing legislation at EU Member States level, please refer to the Member States national reports.
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EU pharmaceuticals legislation provides that a medicinal product may only be placed on the market in the EU if it has received a 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 mirrors the provisions of the Protocol as regards exports of pharmaceuticals.

Transit is not specifically regulated in Swedish or EU law, but the rules for traceability and labelling provide a transparent system if Living Modified Organisms were to be in transit in Sweden.

Article  7 - 10 for release on the market is implemented in legislation at the EU level and these answers will be provided by the Member States and the European Commission (Dir. 2001/18, Reg, 1829/2003 and Reg. 1830/2003).
Directive 2001/18/EC is implemented in Swedish Ordinance (2002:1086). Decisions on intentional introduction to the environment as field trials are however made at national level. This procedure is also regulated in Ordinance (2002:1086) and is in compliance with the provisions of the Biosafety protocol. The regulation for authorisation of LMO is based on the use of a LMO, not the transboundary movement in itself even though import might be one of the areas of use.
32. 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 the exporter's compliance with the rules i.e. Reg. (EU) 1946/2003. 
33.  Regarding exports, the EU legislation (Reg. no 1946/2003) doesn't specifically address the accuracy of the information provided by the exporter. But the penalties laid down in the Swedish Environmental Code Chapter 29 Section 9.7-8 lay down the penalty for violation articles 6, 12 and 13 of Reg. (EU) 1946/2003.
34-39. One of the European authorisation process for release on the market of an LMO (Dir. 2001/18) include that the competent authority that first received a notification shall also write the decision. This was done in by a Swedish authority in 2010. The authorisation is though applicable in all of the European community. Decisions on field trials are taken nationally.
36 - 37 Decisions on field trials are alsways beased on an application that corresponds with the provisions of articles 7-10 and 12. Permission must be given by the proper authority before a release into the environment. There is no difference as to if the LMO is produced within the country or imported.  
We also refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.

Article 11 is implemented in legislation at the EU level. The EU has developed a comprehensive legal framework on GMOs, which 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 taken for placing on the market of LMOs-FFP, it has to be noted that those decisions are taken for the whole European territory and not by the MS individually.      
We also refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.

Article 12 is implemented in legislation at EU level. See Article 20 of Directive 2001/18 and Articles 21 and 22 of Regulation 1829/2003. Sweden has followed the answers as provided by the European Commission for questions 59-62. We also refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.

Article 13 is implemented in legislation at the EU level. The EU has not made use of the simplified procedure for imports of LMOs as specified in Article 13.  We refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.

Sweden is a Member State of the European Union. In the European Union, most of the legislation pertaining to the Cartegena Protocol is harmonised.                                                    

Articles 15 & 16 are implemented in legislation at the EU level. 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 a LMO for cultivation or as food or feed. EU regulation 1829/2003 and 2001:18 apply. Risk assesments are to be evaluated by the competent authorities in all member states. 
Risk assessments for field trials are assessed by competent authorities in Sweden according to national legislation which is in line with EU legislation. 
We refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.

Article 18 is implemented through EU legislation. Directive 2008/68/EC has been included instead of Council Directives 94/55/EC and 96/49/EC, which had been repealed. We refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety. 

Responsibility for administrating and handling GMOs in Sweden is shared by several central authorities, depending on the type of organisms. The Swedish Board of Agriculture has a major roll because most GMOs are agricultural crops.

Regarding question 136. Article 25 in directive 2001/18/EC and article 30 in 1829/2003 implements 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.
Regarding question 136. The notifier is allowed to identify what information it wants to keep confidential. However, the decision on what information to be considered confidential has to be assessed by for the Swedish authority.
We refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.                                                                                           
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 GMOs.
Article 25 of Directive 2001/18/EC on the deliberate release into the environment of GMOs stipulates that the European Commission and the Member States shall not divulge to third parties any confidential information notified or exchanged under this Directive and shall protect intellectual property rights relating to the data received.
Article 30 of Regulation (EC) No 1829/2003 on genetically modified food and feed allows applicants to indicate which information submitted under the Regulation they wish to be treated as confidential, based on verifiable justification.
Article 16 of Regulation (EC) No 1946/2003 on transboundary movements of GMOs obliges the European Commission and the Member States not to divulge to third parties any confidential information received or exchanged under this Regulation. It allows the exporter to indicate the information in the notification that should be treated as confidential, provided that justification is given in such cases.
However, all the above confidentialy provisions make clear what information shall never be considered as confidential, notably as regards the general description of the GMO, the name and address of the authorisation holders, the risk assessment information and any methods and plans for emergency responses.    

                                                                                                 

The Swedish GMO authorities have a joint organisation, the Swedish Gene Technology Advisory Board and website (http://www.genteknik.se) for dissemination of information on GMO regulations, current research and ongoing applications and remits, including a link to the BCH website. Programs are on a national level.
All authorities have specific information on GMOs in relation to their competence on their website. 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. 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 the notifications and is also given the opportunity to send in any comments to the authorities. Depending on the scope of the application and what legislation it is notified within, the public can also submit comments via the Joint Research Centre website, the EC commission or the competent authorities web-sites.
The website of the Swedish Board of Agriculture (http://www.jordbruksverket.se) contains information about which GM crops have been approved for import and/or cultivation within the EU and decisions on field trials in Sweden.
The Swedish gene technology authorities also have a common website (http://www.gmo.nu) to make it easier for people who use gene technology, or who take interest in the subjekt, to find information about the legislation and the requirements that applies to various types of activities.
In Sweden the principle of public access to official documents is applied. All Swedish citizens are entitled to read the documents held by public authorities. This means that documents received as well as dispatched letters, decisions and reports are in principle official documents and must be made available for anyone to read. Access to official documents may however be restricted if they may be kept secret in order to protect specified interests.

The Swedish GMO authorities have a joint organisation, the Swedish Gene Technology Advisory Board and website (http://www.genteknik.se) for dissemination of information on GMO regulations, current research and ongoing applications and remits, including a link to the BCH website. Programs are on a national level.
All authorities have specific information on GMOs in relation to their competence on their website. 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. 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 every notifications and applications for field trials. The public can read summaries of the notifications and is also given the opportunity to send in any comments to the authorities. Depending on the scope of the application and what legislation it is notified within, the public can also submit comments via the Joint Research Centre website, the EC commission or the competent authorities web-sites.
The website of the Swedish Board of Agriculture (http://www.jordbruksverket.se) contains information about which GM crops have been approved for import and/or cultivation within the EU and decisions on field trials in Sweden. Information and decisions about field trials are also published in relevant local newspapers.
The Swedish gene technology authorities also have a common website (http://www.gmo.nu) to make it easier for people who use gene technology, or who take interest in the subjekt, to find information about the legislation and the requirements that applies to various types of activities.
In Sweden the principle of public access to official documents is applied. All Swedish citizens are entitled to read the documents held by public authorities. This means that documents received as well as dispatched letters, decisions and reports are in principle official documents and must be made available for anyone to read. Access to official documents may however be restricted if they may be kept secret in order to protect specified interests.

We refer to the EU's Third National Report on the Implementation of the Cartegena Protocol on Biosafety.

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.

Sweden participates in the European  GMO Socio-Economics Bureau, which aims to facilitate the exchange of technical and socio-implications of the cultivation and use of genetically modified organisms. This group has published a report on the socio-economic implications of the cultivation of Genetically Modified Organisms (GMOs) describing the state of knowledge. https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/framework-socio-economic-analysis-cultivation-genetically-modified-crops