Cabinet Regulation No. 119 of 2006 on Procedures by which a Producer, Distributor of Goods or a Service Provider Informs the Relevant State Supervisory and Control Institutions Regarding the Goods or Services that Cause a Risk Incompatible with General Safety Requirements

Translation © 2015 Valsts valodas centrs (State Language Centre) Text consolidated by Valsts valodas centrs (State Language Centre) with amending regulations of: 14 October 2014 [shall come into force on 17 October 2014]. If a whole or part of a paragraph has been amended, the date of the amending regulation appears in square brackets at the end of the paragraph. If a whole paragraph or sub-paragraph has been deleted, the date of the deletion appears in square brackets beside the deleted paragraph or sub-paragraph. Republic of Latvia Cabinet Regulation No. 119 Adopted 14 February 2006 Procedures by which a Producer, Distributor of Goods or a Service Provider Informs the Relevant State Supervisory and Control Institutions Regarding the Goods or Services that Cause a Risk Incompatible with General Safety Requirements Issued pursuant to Section 8, Paragraph six of the Law On the Safety of Goods and Services 1. This Regulation prescribes the procedures by which a producer, distributor of goods or a service provider shall inform the relevant State supervisory and control institution (hereinafter – market supervisory institution), if such producer, distributor or provider becomes aware of or, as an expert, should have known that the product or service causes a risk incompatible with general safety requirements. 2. A producer, distributor or service provider shall inform the relevant market supervisory institution regarding the goods put into circulation or a service provided if such product or service causes a risk incompatible with general safety requirements. This Regulation does not apply to medicines, medical devices (also in vitro diagnostic medical devices), medicinal products and food. 3. If a product or service causes a risk not only to consumer health and safety, but also to the environment, the producer, distributor or service provider shall inform the State Environmental Service thereof. 4. A producer, distributor or service provider shall not inform market supervisory institutions regarding a product or service that causes a risk in the following cases: 4.1. risk that makes the product or service unsafe applies only to individual expressly known batches of produced goods or separate items, and the producer has withdrawn the goods of these batches or the relevant items or taken the necessary measures in order to ensure the compatibility of the product or service with general safety requirements; 4.2. the producer, distributor or service provider has become aware that the relevant market supervisory institution has already been informed regarding the product or service that causes a risk incompatible with general safety requirements. Translation © 2015 Valsts valodas centrs (State Language Centre) 2 5. In order to determine the conformity of a product or service with general safety requirements, the producer, distributor or service provider shall perform a risk assessment in accordance with the laws and regulations regarding the safety of goods and services. 6. If the producer of a product or a service provider has been the first to receive information that the particular product or service causes a risk incompatible with general safety requirements, the producer or service provider shall immediately, as soon as all the relevant information is available, but not later than within 10 calendar days, complete Part I of the notice form regarding the product or service that causes a risk incompatible with general safety requirements (Annex) and submit the notice to the relevant market supervisory institution, but the copies of the notice – to distributors. If the product or service causes a serious risk, the notice shall be submitted not later than within three working days after all the relevant information has become available. 7. If a distributor has been the first to receive information that a particular product or service causes a risk incompatible with general safety requirements, the distributor shall immediately, as soon as all the relevant information is available, but not later than within 10 calendar days, complete Part I of the notice form regarding the product or service that causes a risk incompatible with general safety requirements and submit the notice to the relevant market supervisory institution, but a copy of the notice – to the producer. If the product or service causes a serious risk, the notice shall be submitted not later than within three working days after all the relevant information has become available. 8. A producer who has received information regarding a product that causes a risk incompatible with general safety requirements from a distributor shall submit additional information regarding the particular product at the request of a market supervisory institution, for example, information regarding other distributors of the product, in order to ensure the traceability of the product. 9. If a producer has also put into circulation the product that causes a risk incompatible with general safety requirements in other Member States of the European Union or European Economic Area, such producer shall immediately, as soon as the relevant information is aggregated, but not later than within 10 calendar days, complete Part II of the notice form regarding the product or service that causes a risk incompatible with general safety requirements and submit the notice to the relevant market supervisory institution. If the product or service causes a serious risk, the notice shall be submitted not later than within three working days after all the relevant information has become available. 9.1 The producer or distributor, in conformity with the time periods referred to in this Regulation, may submit a notice to the relevant market supervisory institution regarding product that causes a risk incompatible with general safety requirements and that has been put into circulation also in other Member States of the European Union or European Economic Area. The notice shall be submitted using the Internet notification online system established by the European Commission (https://webgate.ec.europa.eu/gpsd-ba/). In such case the merchant need not additionally submit the notice referred to in Annex to this Regulation to the relevant market supervisory institution. [14 October 2014] 10. A market supervisory institution shall send the information received from a producer, distributor or service provider to the Consumer Rights Protection Centre – the contact point of the Rapid Information System (RAPEX) in Latvia in accordance with the laws and regulations Translation © 2015 Valsts valodas centrs (State Language Centre) 3 regarding the exchange of information on the measures taken that restrict or prohibit the putting of goods into circulation. 11. Market supervisory institutions shall consult producers, service providers and distributors regarding the notification procedures. Informative Reference to European Union Legal Acts This Regulation contains legal norms arising from: 1) Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety; 2) Commission Decision of 14 December 2004 laying down guidelines for the notification of dangerous consumer products to the competent authorities of the Member States by producers and distributors, in accordance with Article 5(3) of Directive 2001/95/EC of the European Parliament and of the Council. Prime Minister A. Kalvītis Minister for Economics A. K. Kariņš Translation © 2015 Valsts valodas centrs (State Language Centre) 4 Annex Cabinet Regulation No. 119 14 February 2006 Notice Regarding the Product or Service that Causes a Risk Incompatible with General Safety Requirements Part I 1. Information regarding the market supervisory institution that receives the notice: 1.1. name 1.2. given name, surname of contact person 1.3. address 1.4. telephone number 1.5. fax number 1.6. e-mail address 2. Information regarding the producer, distributor or service provider who has been notified regarding the product or item: 2.1. name 2.2. address 2.3. place in the supply chain of the product or item 3. Information regarding the producer, distributor or service provider who completes the notice form: 3.1. name 3.2. given name, surname of contact person 3.3. address 3.4. telephone number 3.5. fax number 3.6. e-mail address 4. Information regarding the product or item: 4.1. category and customs code 4.2. name, trademark, price and country of origin 4.3. name and address of the producer 4.4. model, model number, bar code, batch number 4.5. applicable standards or regulations 4.6. description or photo 5. Information regarding the risk caused by the product or item: 5.1. description of the risk, substantiation and possible harm to health and safety, as well as conclusions after the risk calculation and assessment: Translation © 2015 Valsts valodas centrs (State Language Centre) 5 5.2. information regarding accidents (list): 6. Information regarding the measures taken: 6.1. type 6.2. scope 6.3. duration 6.4. performer of the relevant measure Part II 7. Information regarding other producers, distributors or service providers in the supply chain at whose disposal are the goods or items incompatible with general safety requirements: 7.1. producers, importers, authorised representatives or service providers in other Member States of the European Union (name, address, telephone number, fax number, e-mail address): 7.2. distributors in other Member States of the European Union (name, address, telephone number, fax number, e-mail address): 7.3. the quantity of goods or items (production batch) available to the producer, distributor or service provider. Minister for Economics A. K. Kariņš