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Registration of FCM operators

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The information presented was found or received from and ad-hoc questionnaire to MS competent authorities. It is only as exhaustive as the replies and feedback obtained for the purpose of this report. The data is presented in the format of a summary.

Overview of national measures in the EU MSs regarding information on registration of
business operators:

MSs Legislation FCM registration (for whom) Responsible entity/ Registry Applications for FCM business operators
AT LMSVG (Austrian Food Safety and Consumer Protection Act) All food contact operators

[Art. 6 of Reg. (EC) 852/2004]

Federal Minister for Health, or by the federal institution ‘Statistics Austria’, Provincial Governor for the approval of establishments (as per Food Hygiene Approval Regulation, Federal Law Gazette II No 231/2009)
DK BEK nr. 1007 af 19/09/2014 (Afsnit IV, Kapitel 5, §20) Importers or manufactures of FCM (exemption if market <1,000 pieces and 50,000 kr per year) Danish veterinary and Food Administration website Website contains form to be filled by operators, where the company details, the type of business (with reason for application) and the starting date of the business are requested.
EE Toiduseadus (Food Act) RT I 1999, 30, 415, last amended by RT I, 9.10.2014 All food business operators; in addition to Art. 6 of Reg. (EC) 852/2004 (Ch.1, §8). Veterinary and Food Board Data of operator and business, data of representative and type of business (Ch. 1, §7). Application for registration in the register of economic activities for data on the materials and groups of articles intended to be brought into contact with food (Ch. 4, §31).
ES* Real Decreto 191/2011 FCM operators food businesses and establishments are subject to registration (those located in any other Member State of the European Union may also be entered in the Register Registro General Sanitario de Empresas Alimentarias y Alimentos – Spanish Agency for Food Safety and Nutrition of the Ministry of Health.

– Starting date of business, special authorisations or accreditations required for specific products)

– Requires notification for any amendment of inserted data and communication if cessation of activities, and includes procedure for entry, amendment and cancellation of data.

– Article 38(4) of Law 30/1992 of 26 November 1992 specifies to which bodies of public authorities the applications should be submitted.

FI Elintarvikelaki (Food act) 2006/23,amended by SDK 68/2015 Operators No further description found – more detailed provisions on the registration will be issued in a Ministry of Agriculture and Forestry decree (not available as of yet).
LV Medžiagų ir gaminių, skirtų liestis su maistu, Geros gamybos praktikos taisyklės (Ch. V, 29-44, 6.pielikums). Companies dealing with manufacture, processing and distribution of materials and articles Registry of Surveillance Objects – Company data, type of activity, form

– Procedure for suspension and renewal of distribution and use (annual surveillance program)

NO Forskrift om materialer og gjenstander i kontakt med næringsmidler (matkontaktforskriften), FOR-1993-12-21-1381 Production, importation or sale of FCM Norwegian Food Safety Authority. (Kapittel I, §4c). – Data of premises and responsible person, type of activity, including imports, type of materials)
PL Law 171 poz. 1225 of 25 August 2006 and its amendments (Dział IV, Art. 61, 63-67 ) Food contact operators, 14 days before they are allowed to start their business – district sanitary inspector or

– state border sanitary inspector

– Registration and approval, conditional approval, extending conditional approval, suspension and withdrawal of approval for food businesses

– Article 67 lists all information to be provided for application (location data of company and identification data of responsible person, type of business, start date of activity, information on official controls carried out in the food business).

SI Decree of the Official Gazette of the Republic of Slovenia No 57/2008 of 10.6.2008, p. 6225 Companies that produce, process and first market materials and articles intended to come into contact with foodstuffs. Registration applications can be submitted online, using the official website indicated by the decree. – official form for business / plant details, type of activity, type of materials/products submitted to the authorities for registration

– foresee monitoring of implementation by Health Inspectorate of the Republic of Slovenia (ZIRS)

– includes fines for failing to comply and conditions for withdrawal of registrations.

Regarding Industry guidance documents, Spain has a GMP document (Guia para la Implantación de las buenas prácticas de fabricación para empresas que elaboran materiales y objetos destinados a estar en contacto con alimentos) done by CONSEBRO- Asociación de Industrias Agroalimentarias de Navarra, La Rioja y Aragón, that mentions that companies dealing with FCM must be registered in the Registro General Sanitario de Alimentos (RGSA). It also contains some information about the details required for the registration and who has to register.

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