The scope of this latter directive is slightly wider and thus covers plants that were not subject to reporting before 2015. In the period 20042015, lcps were covered by directive 2001 80 ec, while in 2016 lcps were subject to reporting in accordance with directive 201075eu. This is outlined in european commission guideline, in application of the current clinical trials directive 200120ec and the paediatric regulation. Directive 200118ec of the european parliament and of the council of 12 march 2001 on the deliberate release into the environment of genetically modified.
Directive 200118ec on the deliberate release of gmos into the environment regulates the. A major objective of the european commission monitoring working group mwg on guidance notes supplementing annex vii of directive 200118ec was to explore the possibility of european union euwide coordination and harmonisation of data resulting from monitoring of genetically modified gm crops. Gmo monitoring data coordination and harmonisation at eu. Guideline for the submission of dna directive 200118ec. Official journal no page date m1 council directive 200484ec of 10 june 2004 l 219 8 19. Directive 200118ec on the deliberate release into the.
Shd275314 for distribution and retail under directive 200118ec. Directive 200118ec 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 90220eec. Context of the release as per the requirements of directive 200118ec, this document presents an assessment of the possible risks to the environment following deliberate release of a genetically modified organism. Authorities and the european commission and invites any feedback, as appropriate, on this proposal for action. Scientific opinion on the revised molecular characterisation. A general overview is provided by francescon, the new directive 200118ec on the deliberate release of genetically modified organisms into the environment. This consolidated text includes directive 200118ec on the deliberate release of gmos into the environment, commission decision 2002623ec establishing guidance notes supplementing annex ii to directive 200118ec on risk assessment, regulation ec 18292003 on gm food and feed and regulation ec no 18302003 concerning the traceability and labelling of gmos. Request from the european commission related to the safeguard clause invoked by austria on oilseed rape ms8, rf3 and ms8xrf3 according to article 23 of directive 200118ec 1 scientific opinion of the panel on genetically modified organisms. Rsvped011 clinical study chad155rsv directive 200118.
The completion of the internal market must lead to an improvement in the living and working conditions of workers in the european community. The aim of this guideline is to define minimum requirements and recommendations for. Since 2001, new genetic modification techniques have been developed at. Directive 200118ec of the european parliament and of the council. F3 substituted by directive 200827 ec of the european parliament and of the council of 11 march 2008 amending directive 2001 18 ec on the deliberate release into the environment of genetically modified organisms, as regards the implementing powers conferred on the commission. The annex currently in force is laid down in commission directive 200363 ec of 25 june 2003 amending directive 200183 ec of the european parliament and of the council on the community code relating to medicinal products for human use official journal l 159, 2762003 p. Restrictions are intended to be temporary and must be justified by new scientific information indicating that the gmo poses a risk to human health or the environment. Commission directive 200122ec of 8 march 2001 laying. Pdf request from the european commission related to the. Firstly, we present concepts for the coordination and harmonisation. Ec administrative procedure for granting consents for the deliberate release into the environment of gmos continue.
B directive 200120ec of the european parliament and of the council of 4 april 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use oj l 121, 1. Yes no i if no, refer to risk analysis data on the basis of the elements of part b of directive 2001 18 ec 5. What this means for clinical trial sponsors for clinical trials that ended on or after 21 july 2014, sponsors will have to post results within six paediatric clinical trials or 12 months non. This consolidated text includes directive 200118ec on the deliberate release of gmos into the environment, commission decision 2002623ec establishing guidance notes supplementing annex ii to directive. In doing so, the principle that the environmental risk assessment should be carried out on a casebycase basis should be respected. Yes no i if no, refer to risk analysis data on the basis of the elements of part b of directive 2001 18 ec. It replaced and updated the law previously known as the acquired rights directive 77187ec.
F2 labs can assist you in testing the product to the appropriate standards under the general product safety directive 200195ec. Directive 200118ec 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 90220eec commission declaration official journal l 106, 17042001 p. Legal analysis of the applicability of directive 200118. 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 notice to applicants, volume 2a procedures for marketing authorisation, chapter 3 union referral procedures dated november 2018 2. This consolidated text includes directive 200118ec on the deliberate release of gmos into the environment, commission decision 2002623 ec establishing guidance notes supplementing annex ii to directive 200118ec on risk assessment, regulation ec 18292003 on gm food and feed and regulation ec no 18302003 concerning the traceability and labelling of gmos.
Directive 200118ec as regards the possibility for the member states to restrict or prohibit the cultivation of genetically modified organisms gmos in their territory oj l 68. B directive 200120ec of the european parliament and of the council of 4 april 2001. The directive 200119ec of the european parliament and of the council of 14 may 2001 controls the general system for the recognition of professional qualifications of nurses responsible for general care, dental practitioners, veterinary surgeons, midwives, architects, pharmacists and doctors in the european union. In the period 20042015, lcps were covered by directive 200180ec, while in 2016 lcps were subject to reporting in accordance with directive 201075eu. Directive 2001 18 ec was amended by directive 200827 ec. Official journal no page date m1 commission decision 2002623ec of 24 july 2002 l 200 22 30. L 7714 en official journal of the european communities 16. Council decision concerning the provisional prohibition of. Directive 90220eec of 23 april 1990 on the deliberate release into the environment of. Directive as last amended by commission directive 199983ec oj l 243, 15. Directive 200183ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use notice to applicants, volume 2a procedures for marketing authorisation, chapter 3 union referral procedures dated november 2018 2. The directive 200119ec of the european parliament and of the council of 14 may 2001 controls the general system for the recognition of professional qualifications of nurses responsible for general care, dental practitioners, veterinary surgeons, midwives, architects, pharmacists and doctors in the european union the directive 200119ec amends council directives 8948ec and 9251ec on.
Wtds291r wtds292r wtds293r page a5 request for further information, comments or reasoned objections by the commission or the member states. Is the product being simultaneously notified to another member state. Directive 2001 45 ec of the european parliament and of the council of 27 june 2001 amending council directive 89655eec concerning the minimum safety and health requirements for the use of work equipment by workers at work second individual directive within the meaning of article 161 of directive 89391eec text with eea relevance. Directive 200118ec of the european parliament and of the council of 12. The annex currently in force is laid down in commission directive 200363ec of 25 june 2003 amending directive 200183 ec of the european parliament and of the council on the community code relating to medicinal products for human use official journal l 159, 2762003 p.
Request from the european commission related to the safeguard. Council directive 200123ec of 12 march 2001 on the. B directive 200118ec 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 90220eec oj l 106, 17. Directive 200145ec of the european parliament and of the. It replaced and updated the law previously known as the acquired rights directive 77187 ec. Directive 200118ec on the deliberate release into the environment of genetically modified organisms. Yes no i if no, refer to risk analysis data on the basis of the elements of part b of directive 200118ec 5.
The current version of the gpsd came into force 15th january 2004. Directive 200118ec regulates the introduction of genetically modified gm organisms into the environment. Directive 200184ec of the european parliament and of the. 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 90220eec commission declaration. Directive 200184ec of the european parliament and of the council of 27 september 2001 on the resale right for the benefit of the author of an original work of art the european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 95 thereof. This document is meant purely as a documentation tool and the. Guideline for the submission of dna directive 200118ec and. Application to import cutflowers of carnation dianthus. Transfers of undertakings directive 2001 wikipedia. Therefore, no specific scientific evidence, in terms of risk to human and animal health and the environment, were provided that would justify the invocation of a safeguard clause under article 23 of directive 2001 18 ec.
Eurostation ii place victor horta victor hortaplein, 40 box 10. B 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 90220eec oj l 106, 17. Directive 2001 18 ec of the european parliament and of the council of 12 march. Yes no i if no, refer to risk analysis data on the basis of the elements of part b of directive 200118ec.
Official journal no page date m1 commission decision 2002623 ec of 24 july 2002 l 200 22 30. An overview of the general product safety directive 200195ec. Directive as last amended by commission directive 199983 ec oj l 243, 15. Directive 2001 18 ec of the european parliament and of the council show full title. B council directive 20011ec of 20 december 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut puree intended for human consumption oj l 10, 12. This text does not contain the annex to directive 200183 ec. Directive 200114ec of the european parliament and of the council of 26 february 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification, official journal l 075 15032001 p. Guideline for the submission of dna sequences derived from genetically modified organisms and associated annotations within the framework of directive 200118ec and regulation ec no 18292003 february 2016 with explanations of april 2017 introduction. Guideline for the submission of dna sequences derived from genetically modified organisms and associated annotations within the framework of directive 2001 18 ec and regulation ec no 18292003 february 2016 with explanations of april 2017 introduction. Request from the european commission related to the. Rsvped011 clinical study chad155rsv directive 200118ec. L10710 en officialjournaloftheeuropeancommunities 18. 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 90220eec commission declaration official journal l 106, 1704 2001 p. This is outlined in european commission guideline, in application of the current clinical trials directive 2001 20 ec and the paediatric regulation.
In addition a separate application has been submitted to the. Directive 2001 18 ec of the european parliament and of the council of 12 march 2001 on the deliberate release into the environment of. Directive 200118ec of the european parliament and of the council of 12 march 2001 on the deliberate. Therefore, no specific scientific evidence, in terms of risk to human and animal health and the environment, were provided that would justify the invocation of a safeguard clause under article 23 of directive 200118ec. Commission directive 200122ec of 8 march 2001 laying down.
Pursuant to article 351 of directive 200118ec which replaced directive 90220eec procedures in respect of notifications concerning the placing on the market of genetically modified organisms which have not been completed by 17 october 2002 are subject to the provisions of directive 200118ec. 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 90220eec. Article 1 paragraph 1 the purpose of this directive is to ensure that products placed on the market are safe. Implementation of directive 2001 18 ec is also closely linked with directive 91414eec on the placing of plant protection products on the market, as amended. Directive 200180ec, large combustion plants european. Genetically modified organisms gmo environmental protection. Directive 200118ec on the deliberate release into the environment of gmos. The transfers of undertakings directive 200123ec is a european union law that protects the contracts of employment of people working in businesses that are transferred between owners. After exit day no further amendments will be applied to this version. B council directive 2001110ec of 20 december 2001 relating. Commission directive 199910 ec, directive 2000 ec of the european parliament and of the council, commission directives 200267 ec and 20085 ec and commission regulation ec no 6082004 oj l 304, 22. This document is meant purely as a documentation tool and. General product safety directive 200195ec testing f2 labs. European communities, council directive 75129eec of 17 february 1975.
We offer expert product safety testing, inspection and certification, as well as fast turnaround times. Legal analysis of the applicability of directive 200118ec. Directive 200118ec of the european parliament and of the council show full title. The transfers of undertakings directive 2001 23 ec is a european union law that protects the contracts of employment of people working in businesses that are transferred between owners. Directive 90220eec with abstentions by france, 4 directive 200118ec on the deliberate release into the environment of gmos 2 council directive of 23 april 1990 on the contained use of genetically modified microorganisms 90219eec, oj 1990 l 1171, as amended by directive 9881ec of 26 october 1998, oj 1998 l 330. Cnl0010 to import 1507 maize has been submitted to the netherlands in accordance with directives 90220eec and 2001 18 ec. Directive 200124ec of the european parliament and of the. B council directive 20011ec of 20 december 2001 relating. Directive 200118ec of the european parliament and of the. Directive 2001 14 ec of the european parliament and of the council of 26 february 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification, official journal l 075 1503 2001 p. Council directive 2001 23 ec of 12 march 2001 on the approximation of the laws of the member states relating to the safeguarding of employees rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses official journal l 082, 2203 2001 p.