Machinery Best practices in market surveillance

Transcription

1 UN ECE WP6 MARS Praha Machinery Best practices in market surveillance Kvetoslava Steinlová

2 UN ECE WP6 MARS Machinery Best practices in market surveillance Control on the border previous legal background NLF MS and Customs Authorities Risk assessment Task Force ADCO

3 Control on the border Former Council Regulation 339/93/EEC and executing decision Commission Decision of 28 July 1993 establishing the list of products provided for in Article 8 of Council The purpose of the Regulation was twofold: to Provide Customs with the legal basis to suspend the release of unsafe products, to Introduce detailed comparable rules throughout Member States regarding the suspension of the release of products and the procedure connected therewith (cf. 3. for more details).

4 Scope of the Council Regulation 339/93/EEC In principle, it applied to products imported from third countries whether or not they are covered by New Approach Directives. According to Article 8 of the Regulation a list of products which are more specifically covered by the second indent of Article 21 was drawn up in a Commission Decision, The Regulation itself does not stipulate any specific obligation addressed to customs authorities as to the control of products imported from third countries, but provides a legal basis allowing customs authorities under certain conditions to detain suspect unsafe goods: When, during checks of goods entered for release to free circulation, customs find that a product displays characteristics which would give rise to a serious doubt as to the existence of a serious and immediate risk to health or safety in the event of the product being used under normal and foreseeable conditions they may suspend the release for up to three working days.

5 Regulation for goods import into the territory of the European Union Regulation (EEC) No 339/93, OJ L 279, 12/11/1993, p. 39. [ ] that list shall be revised, as and when necessary, in order to adapt it to the new situations resulting from the experience and development of the rules on product safety. Council Regulation 2913/92 of 12 October 1992 establishing the Community Customs Code, OJ L 302, The indicatory list of product toys foodstuffs Medicinal products for human use Medicinal product for veterinary use Indicative list but it was not revised as provided for in Article 8 of the Regulation CERTIF : Strengthening the Impact of Regulation 339/93 on checks for conformity with the rules on product safety in the case of products imported from third countries

6 Regulation 339/93/EEC According to Article 13 the customs authorities may, in accordance with the conditions laid down by the provisions in force, carry out all the controls they deem necessary to ensure that customs legislation is correctly applied. Article 68 empowers the customs authorities to examine documents as well as goods and to take samples in order to check a customs declaration. Customs Code constitutes the legal basis for customs actions. It contains, however, no specific obligations for customs authorities how to proceed with regard to checks on conformity.

7 When? Regulation 339/93/EEC What? Products presenting serious risks and non compliant Article 2.2: When [ ] the customs authorities find [ ] that a product [ ] is not accompanied by a document or not marked in accordance with the Community or national rules on product safety [ ] How? Through Cooperation and Information exchange - Council Regulation 515/97 on mutual assistance between the administrative authorities of the Member States and cooperation between MS and the Commission to ensure the correct application of the law on customs and agricultural matters, OJ L 082, 22/03/1997

8 Information exchange on the EU border RAPEX: intended for consumers or likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them EP and Council Regulation 765/2008/EC (one of the New Approach revision results): RAPEX extended to industrial products ICSMS set up to work at EU level, RIF to be complemented by safety aspect RIF (Risk Information Form) issued by the Commission or by any Member State authority which is linked to the system (mainly airports, risk centres). RIF usually prepared following a finding of an irregularity to exchange risk information between customs offices and authorities concerned with regard to a potential irregularity. From RIFs mainly used for irregularities like misdeclarations, counterfeiting or undeclared goods

9 Regulation 764/2008/EC Article 12.4 Commission shall draw up, publish and regularly update a non-exhaustive list of products which are not subject to Community harmonisation legislation. It shall make that list accessible through a website. Existing IT tool - Export Helpdesk for Developing Countries - trade facilitation tool to assist developing countries exporters to access the EU market, accessible free of charge (EN, ES, FR and PT languages) Harmonized as well as non harmonized products

10 Information available in the Export Helpdesk

11 Requirements and Taxes section: Requirements of the European Union and of the Member States, applicable to the import of this product from third countries

12 An example with an harmonised product

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15 NLF - Regulation 765/2008/EC Article 22) extends RAPEX to: Consumer and Professional goods All risks including those others than health and safety Restrictive Measures (obligatory, voluntary) new types of notifications in RAPEX ( ) Goods for Professional use : Machineries for use in workplace, Equipment for use in potentially explosive atmospheres, Motor vehicles, Chemical products: fertilisers infringing Reg 2003/2003 Risks others than health and safety (e.g. environmental risk): Plastic products and plastic packages of various consumer products containing cadmium (REACH Regulation), Fireworks infringing Reg. 850/2004 (persistent organic pollutants)

16 Regulation 765/2008/EC- Control of imported products Obligation of border controls on an adequate scale before release for free circulation (Articles 27 to 29 of NLF Regulation) customs must suspend release for free circulation they must inform Market Surveillance Authorities (MSA) MSA can prohibit marketing if products dangerous Apply to all products covered by EU legislation Cooperation with customs is a key factor Guidelines for the common understanding RATF and Customs

17 area RATF- RISK ASSESSMENT TASK FORCE TASK RA based on RAPEX extended to harm. Disadvantages of application of RAPEX guidelines in harmonised fields Focus on persons Limited scope scenarios Demand for empirical data Less obvious link to standards / benchmarks No of category s of hazards CERTIF

18 RATF Guidelines Stronger emphasis on consideration of standards in hazard identification, and, decision making More reliable links with Essential Requirements Adapted to scope products Clarification on use, compliance assessment, (after placing on market) Use of abstract harm phrases

19 Abstract description of harm Severe Injury (RAPEX) Injury or consequence that is or could be fatal, including brain death; consequences that affect reproduction or offspring; severe loss of limbs and/or function, leading to more than approximately 10 % of disability Alternative (RATF) Large negative effect, irreversible in more aspects, whether or not acute. If the effect is quantifiable, setting a limit is preferable.

20 Reference to Standards stronger influence of EN Stds / benchmarks

21 Reference to Standards 2 stronger influence of EN Stds / benchmarks

22 Risk Assessment in Practice Circular Saw Top guard cannot be adjusted = SERIOUS RISK No top guard = SERIOUS RISK No instructions Professional Use Medium Risk No instructions Non - Professional Use High Risk

23 Risk Assessment in Practice Circular Saw in Rapex Matrix Operator severs fingers on rotating blade Abstract Irreversible harm NO top guard Top guard cannot be adjusted No Instr Non-Proff Use No Instr Proff Use Combination of severity and probability to risk level Probability of occurrence of the harm scenario (during the foreseeable lifetime of the product) Severity of harm High > 50 % High risk > 1/10 > 1/ Medium risk Medium risk Serious risk Serious risk Serious risk > 1/1.000 Low risk High risk > 1/ Low risk Medium risk > 1/ Low risk Low risk Serious risk Serious risk Serious risk Serious risk High risk Medium risk > 1/ Low risk Low risk Low risk Benchmark Based on EN Standard Serious risk Serious risk Serious risk Serious risk Serious risk High risk Medium risk Low < 1/ Low risk Low risk Low risk Low risk ## ## ## ## ## ## ## ## # # # # # # # #

24 Results of the Risk Assessment in Practice shall be transferred to the customs authorities via proper information exchange based on the cooperation agreements between customs authorities and Market surveillance authorities (MSAs)

25 DG TAXUD Guidelines Structure 1. Generic Part 2. Specific part 3. Annexes including: Legal framework description Indicative lists of EU legal acts to which Regulation 765/2008 applies or not (positive and negative lists). Table with list of the different authorities in each MS involved in import controls in the area of product safety and their responsibilities.

26 Purpose Elements of generic part of the Guidelines Objectives Target audience Overview of EU legislation including clarifications of legal requirements and scope of the border controls Operational procedures Principles of cooperation between Customs and MSAs Recommended elements to be included in national agreements

27 Specific part of the Guidelines Covers concrete product groups Simple and with harmonised structure including: Information sheets for the individual product groups Checklists for the individual product groups Initially 26 product groups- with possibility of further extension in the future

28 Household lamps DG TAXUD Guidelines sectoral Radio- and telecommunications terminal equipment Oil lamps for indoors use Dimethylfuma-rate in leather products/shoes Chain saws Toys Visibility clothing LED Tubes Sunglasses Gas barbeques Portable luminaires Medical devices Helmets

29 DG TAXUD Guidelines generic and sectoral 2 Recreational crafts Portable gas stove Jammer Toys small balls Lighters Household pressure cookers Xmas lighting and chains Construction material Cement Cement Mixer machine Gloves Children's crayons Adaptors Food mixers

30 group Information sheet Detailed information about specific product Allows Customs as final user to quickly find and understand the particular product safety requirements of the product group. Based on a common structure and agreed elements for all product groups

31 INFORMATION SHEET Example of Information sheet - Luminaries - lightning chains, Christmas lightning chains and similar products - Date:.. Legal base Version: 0.1/.. Background, purpose and specific risks related to the particular product 3. CN codes concerned and description of the product including photos of typical examples on compliant and non-compliant goods 4. Reference to applicable harmonised and other standards 5. Safety requirements 6. Indications whether special caution should be considered when handling goods 7. Required documentation 8. Explanation of elements in the checklist

32 Regulation 765/2008/EC and Decision 768/2008/ES EU Regulation 765/2008/EC (RAMS) which includes requirements for cooperation between member states, control at borders, sets ICSMS as an EU wide system and brings work equipment under RAPEX, as well giving the opportunity for some Commission funding Decision 768/2008/EC. Should be considered as good practice, although not legally binding in relation to machines. Commission paper, SOGS-MSG, CERTIF REV1 - Overview of market surveillance procedures (including safeguard clause mechanism) in the area of harmonised products. 32

33 General Principles The MSA who finds a non-conforming machine on their market ( initiating authority / MSA- 1 ) should normally handle the case and get the manufacturer to solve the problem, even if based in another country. Above agrees with the New Legislative Framework MSA-1 should try to get voluntary compliance in all EU/EEA. In many cases manufactures are cooperative and is the most efficient solution. 33

34 General Principles 2 MSA-1 should not rely on other MSA to solve the problem Passing cases to other Member states is generally unacceptable MSA-1 should keep the MSA in the member state of the manufacturer ( MSA-2 ) informed and copies of relevant letters The MSA-2 can, if necessary, be requested to assist in obtaining the technical documentation. Only exceptionally should case is handed over to MSA-2. 34

35 ADCO Machinery Guide(s) COM guide to the Machinery Directive 2006/42/EC. Court ruling from 2005, Yonemoto vs. Finnish Government. Concerning obligations of machine distributors (referred to as importers in the ruling, as Yonemoto had imported the machine from France) Best practice of the Member States Risk assessments for project Market Supervision Car Lifts A 1090 ect. 35

36 Flow chart showing main steps of intervention procedure MSA-1 becomes aware of a problem MSA-1 makes inquiry to the manufacturer (and MF representative and NB if relevant). Dialog/visits etc. MSA-1 makes conclusion on non-conformities. Manufacturer is requested to solve the problem voluntary in all EU Most problems will be solved here and case can be closed MSA-1 takes enforcement action against the manufacturer (sales ban, withdrawal, recall, restrictions). Valid in MSA-1 country. MSA-1 makes Rapex- and Safeguard action notification if relevant EU Commission gives their opinion All MS to make sure that problem is solved in their country. Good practice for market surveillance intervention in the machine sector MD ADCO

37 Standard letters and Gap Analysis The good practice guide contains recommendations for the content of the formal letters used in a case. Also the guide contains actual examples of standard letters used by MSA. It is recommended that all MSA s makes a GAP analysis. The traditional questions should be asked: Where are we? and Where do we want to be? It may be the case that it is not possible for all MSA s to follow the recommendations in the good practice guide. An overview of the situation should be established at a later ADCO meeting. 37

38 Discussion on main principals and how we plan to seek approval of the guide Does the ADCO support the key principals? Initiating Authority Approach Address manufacturer or his authorised representative Seek compliance across all EU/EEA Is it useful to have checklist of phases to follow and examples of standard content of letters? 38 Draft paper on CIRCA, members of the MD ADCO were asked to consider this in details further discussion in October MD ADCO meeting.

39 Thank you for your attention