Framework regulation no 1935 2004 on food contact materials. Regulation ec 1935 2004 european implementation assessment study on 16 july 2015, the coordinators for the european parliaments committee on environment, public health and food safety requested authorisation to draw up an implementation report on the food contact materials regulation ec no 1935 2004. The consolidated version of the regulation ec no 19072006 of the european parliament and of the council on the registration, evaluation, authorisation and restriction of chemicals reach. Regulation ec no 1935 2004, article 16 declaration of compliance for materials and articles intended to come into contact with food note. Regulation ec no 1935 2004 of the european parliament and of the council show full title. The safety of food contact materials is tested by the business operators placing them on the market, and by the competent authorities of the member states during official controls. Current legal framework for nonharmonised materials. The principles set out in regulation ec no 1935 2004 require that materials do not. Ar ticle 51e of regulation ec no 1935 2004 establishes that specific limits on the migration of cer tain constituents into or onto food should take due account of other possible sources of exposure to those constituents. Scientific knowledge and technical competence on testing methods is being maintained by the european reference laboratory for food contact materials eurlfcm. Click here to download the sample doc in pdf format. There are various transitional provisions for this new regulation, and migration testing and supporting documents are needed. Regulations in place in the eu and us are the most widely used international regulations for food contact materials fcms, although other countries, such as canada, china and japan have their own regulations.
Regulation ec no 1935 2004 of the european parliament and of the council of 27 october 2004 on materials and articles intended to come into contact with food constitutes the legal basis for the authorisation and use of food contact materials fcm in the european union eu. It sets out the general principles of safety and inertness for all food contact materials fcms. Regulation ec no 1935 2004, article 16 declaration of compliance for materials and articles intended to come into contact with food this position paper is intended only as a guide and offers only an overview of the declaration of compliance in accordance with regulation ec no 1935 2004 of 27 october 2004. Commission regulation eu no 102011 is a specific measure of regulation ec no 1935 2004 and establishes the specific rules for plastic materials and articles to be applied for their safe use. Regulation ec no 1935 2004 of the european parliament and of the council of 27 october 2004 on materials and articles intended to come into contact with food and repealing directives 80590eec and 89109eec. Technical guidelines on testing the migration of primary. This regulation applies to fcm, including active and intelligent fcm, which in their finished. Regulation ec no 1935 2004 of the european parliament and of the council of 27 october 2004 on materials and articles intended to come into contact with. May, 2016 the regulation sets up a general safety requirement applicable to all possible food contact materials and articles, and envisages a possibility for the adoption of specific safety requirements i. Article5 1 of that regulation provides for the adoption of.
Recommendation of the european chemicals agency of 10. Component fill fluid of measuring cell remote seals process connections remote seals mlfb range 7mf812 7 7mf4 7 material neobee m20. Therefore, food contact materials are subject to legally binding rules at eu level, currently laid down in regulation ec no 19352004 which. Call for technical and toxicological data on the substances. Commission has been committed by regulation ec no 882 2004 of the european parliament and of the council of 29 april 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules 7 to support developing countries with regard to food. We hereby declare that the product sit rans p300 and dsiii conforms to regulation ec no 1935 2004 and fda as described below relating to materials and articles intended to come into contact with food. Regulation ec no 1935 2004 of the european parliament and of the council of 27 october. Directive ec 1935 2004 has been effective since 3 december 2004 as a directly applicable and binding law in all member states of the european community. Regulation of the european parliament and of the council on the transparency and sustainability of the eu risk assessment in the food chain and amending regulations ec no 1782002, ec no 18292003, ec no 18312003, ec no 20652003, ec no 1935 2004, ec no 312008. Regulation ec no1935 2004 lays down the general principles for eliminating the differences between the laws of the member states as regards food contact materials. No 1935 2004, ec no 312008, ec no 11072009, eu 20152283 and directive 200118 ec text with eea relevance the european parliament and the council of the european union. Regulation ec no 1935 2004 of the european parliament and of the council is up to date with all changes known to be in force on or before 17 april 2020.
Ec no 20652003 on smoke flavourings, regulation ec no 1935 2004 on food contact materials, regulation ec no 312008 on the common authorisation procedure for food additives, food enzymes and food flavourings, regulation ec no 11072009 on plant protection products and regulation eu no 20152283 on novel. Administrative guidance for the preparation of applications. Changes that have been made appear in the content and are referenced with annotations. Therefore, in accordance with ar ticle 6 of that regulation, member states have been able to maintain or adopt national. Article 4 set out special requirements for active and intelligent materials.
Regulation ec no 1782002 of the european parliament and of the council of 28 januar y 2002 laying down the general principles and. Food contact materials nordic council of ministers. Regulation ec no 19352004, article 16 declaration of. Article 16 of the regulation necessitates a written declaration of compliance. Fcms shall not release their constituents into food at levels harmful to human health or change food composition, taste and odour in an unacceptable way.
Materials and articles in contact with food weld neck glass disc oring. Regulation ec no 1935 2004 of the european parliament and of the council, article 17 is up to date with all changes known to be in force on or before 06 april 2020. Commission regulation ec no 19352006 of 20 december 2006 amending regulation ec no 794 2004 implementing council regulation ec no 6591999 laying down detailed rules for the application of article 93 of the ec treaty. Although eu member states may have their own legislation, regulation ec no. This regulation lays down the rules on good manufacturing practice gmp for the groups of materials and articles intended to come into contact with food listed in annex i to regulation ec no. Recommendation of the european chemicals agency of 10 july. Corrigendum to commission regulation ec no 19352006 of 20 december 2006 amending regulation ec no 794 2004 implementing council regulation ec no 6591999 laying down detailed rules for the application of article 93 of the ec treaty official journal of. It is eus framework regulation and sets out general requirements for all food contact materials fcms. Release their constituents into food at levels harmful to human health. Commission regulation ec no 19352006 of 20 december 2006.
Regulation ec no 19352004 or framework regulation of the european parliament and of the council of 27 october 2004 sets general requirements applying. The regulation sets up a general safety requirement applicable to all possible food contact. There are changes that may be brought into force at a future date. With its food grade range, jacob is the first and only manufacturer of modular pipe systems in europe to meet the requirements of both the ec 1935 2004 and the fda. Regulation ec no 19352004 of the european parliament and of the. Regulation ec no 1935 2004 of the european parliament and of the council of 27 october 2004 on materials and articles intended to come into contact with food and repealing directives 80590eec and 89109eec the european parliament and the council of the european union. Regulation on materials and articles in contact with food ek date for1993122181 ministry of health and care services published in 1993 1824. Ar ticle 5 of regulation ec no 1935 2004 have been adopted as regards bpa in plastic mater ials and ar ticles, such measures have not been adopted as regards bpa in var nishes and coatings at the union level. Commission regulation ec no 1935 2004 provides a harmonised legal eu framework. Regulation ec no 1935 2004 of the european parliament and of the council of 27 october 2004 on materials and articles intended to come into contact with food and repealing directives 80590 eec and 89109 eec oj l 338. Regulation ec no 1935 2004 of 27 october 2004 states that the materials and articles that come into contact with or that are intended for contact with foodstuffs must be inert towards the foodstuffs. Regulation ec no 726 2004, directive 200182ec, andor directive 200183ec none none 12 regulation ec no 1935 2004 of the european parliament and of the council of 27 october 2004 on materials and articles intended to come into contact with food and repealing directives 80590eec and 89109eec oj l 338. Article 15 of regulation ec no 1935 2004 sets out the rules for the labelling of fcm it states that all fcms that are not yet in contact with foodstuffs must be accompanied by.
Commission regulation ec no 19352006 down detailed rules. According to regulation ec no 1935 2004 of the european parliament and of the council on materials and articles intended to come into contact with food, efsa is asked to carry out an assessment of the risks related to the intended use of the substance and to deliver a scienti. The commission has been committed by regulation ec no 882 2004 of the european parliament and of the council of 29 april 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules 7 to support developing countries with regard to food safety. Food contact materials regulation ec 19352004 think tank. Regulation eu no 102011 on plastic materials and articles. Commission regulation ec no 19352006 of 20 december. Eu food contact regulations for safe food processing. Corrigendum to commission regulation ec no 19352006 of 20 december 2006 amending regulation ec no 794 2004 implementing council regulation ec no 6591999 laying down detailed rules for the application of article 93 of the ec treaty official journal of the european union l 407 of 30 december 2006. Commission regulation ec no 19352006 down detailed. Commission regulation eu no 102011 of 14 january 2011. Regulation ec no 19352004 of the european parliament and of.
Article 3 contains general safety requirements such as not endanger human health, no unacceptable change in the composition and no deterioration of the organoleptic characteristics. Regulation ec no 19352004 of 27 october 2004 states that the materials and articles that come into contact with or that are intended for contact with foodstuffs. This is to certify that super lube and synco lube products are in compliance with regulation ec no 1935 2004 of the european parliament and of the council of 27 october 2004, on materials and articles intended to come into contact with food. All food contact materials fcms need to comply with.
Thus, without eu specific measures for some fcms, the general eu fcm safety requirement, established by framework regulation ec no 19352004, could not. Ec 1935 2004 of 27 october 2004 and ec 20232006 of 22 december 2006 model standard pump spfg05ppx diaphragm pump part no spfg05ppp, spfg05ppt materials used in this equipment that are intended to contact food belong to the groups of materials listed in annex 1 ec. Ec 1935 2004 of 27 october 2004 and ec 20232006 of 22 december 2006 model standard pump spfg05ppx diaphragm pump part no spfg05ppp, spfg05ppt materials used in this equipment that are intended to contact food. Machine translation of regulation on materials and. Regulation ec no 19352004 of the european parliament and. Regulation ec no 20232006 in accordance with eu commission regulation no.
The regulation sets up a general safety requirement applicable to all possible food contact materials and articles, and envisages a possibility for. The regulation sets up a general safety requirement applicable to all possible food contact materials and articles, and envisages a possibility for the adoption of specific safety requirements i. For the application of this principle of inertness to different types of material, application texts. Commission regulation eu 201990 of 31 july 2019 amending, for the purpose of its adaptation to technical progress, the annex to regulation ec no 4402008 laying down test methods pursuant to regulation ec no 19072006 of the european parliament and of the council on the registration, evaluation, authorisation and restriction of. However, this document is provided for general guidance information purpose only. International regulations for food contact materials p1034. Enen 1 2 draft 3 commission regulation 4 on recycled plastic materials and articles intended to come into contact with foods and 5 amending commission regulation ec no 20232006 6 text with eea relevance 7 the commission of the european communities, 8 having regard to the treaty establishing the european union, 9 having regard to regulation ec no 1935 2004 of the european. Food contact materials food safety european commission. European union in europe, the framework regulation ec no 1935 2004 is the basic legislation that applies to all fcms. These rules apply to all sectors and to all stages of manufacture. Regulation ec no 1935 2004 which aims at ensuring fcm safety but also the effective functioning of the internal market in fcm goods. Regulation ec no 19352004 of the european parliament and of the council of 27 october 2004 on materials and articles intended to come into contact with. This position paper is intended only as a guide and offers only an overview of the declaration of compliance in accordance with regulation ec no 1935 2004.