GS mark - Client Information Letter. TÜV Rheinland s GS mark approval procedure. Germany CLIENT GUIDELINES. Version: EN Page 1 of 19

Transcription

1 TÜV Rheinland s GS mark approval procedure Germany CLIENT GUIDELINES Version: EN Page 1 of 19

2 Guideline for TÜV Rheinland s GS mark approval procedure according to the " Product Safety Act" (ProdSG) On , the new "Product Safety Act" (ProdSG) has replaced the former "Equipment and Product Safety Act" (GPSG). The new ProdSG contains more concrete guidelines for consumer products (as defined in 2 (26)) and sharpens sanctions for violations against the Act. Acc. to 20 (1) ProdSG, only ready-to-use products may bear the GS mark. TÜV Rheinland GS-certifies only products that by construction do not present a hazard when used in the German market. GS mark requirements: The GS mark indicates conformity of the tested product with the requirements of 21 of the ProdSG, as well as other statutory provisions (concerning the ensuring of safety and health). The items listed below represent issues that need to be addressed most often. Additional requirements may apply, depending on the product. Version: EN Page 2 of 19

3 Contents: 1. Instructions for use 2. Marking of Name and Address in case of consumer products 3. EMC 4. Acoustic Noise 4.1 In a working environment. 4.2 Household Appliances (airborne noise) 4.3 Noise emission in the environment by equipment for use outdoors 4.4 GS-mark for IT equipment in combination with Visual Display Units (EK1-ITB 2000:xxxx) 5. German law "Food and Feed Code" (LFGB) 6. EMF- Electromagnetic fields 7. WEEE Directive (2002/96/EC) - Waste Electrical and Electronic Equip. 8. RoHS Directive (2011/65/EU; 2002/95/EC) - Restriction of Hazard. Subst. 9. The validity period of a GS mark license 10. Multiple models on GS mark licenses 11. Power Supply Cord Sets included with a GS certified product 12. Factory inspections 13. Use of Swiss plug type Testing and Validation of PAH (in products) for GS-Mark Certification 15. Service offer and Chemical testing 16. "China Export" mark (CE) rumours 17. Labelling of energy-related products 18. Battery Directive 19. Dimethyl fumarate (DMF) - Effects on GS certification 20. Acceptance of CB Certificates and CB Test Report for GS 21. ECODESIGN Directive (2009/125/EC) - Energy related products (ErP) Annex 1: Examples of TÜV Rheinland GS marks Version: EN Page 3 of 19

4 1. Instructions for use Safety and/or health related instructions for use and warning labels in German language ( 6 (1) 1 ProdSG) have to be provided for all models distributed in the German market. Safety and/or health relevant information and instructions have to be provided to the end user in paper form (CD/DVD is not acceptable - source: EK1/AG1, protocol of 12th meeting ). However, there may be standards which require provision of manuals in addition in other forms besides paper (see e.g /A13, 7.12.Z101). The safety and/or health related instructions for use in German language have to be provided during the documentation process before Certification can be proceeded. 2. Marking of Name and Address in case of consumer products Consumer products (term is defined in 2 (26) ProdSG) shall have a unique identification marking (e.g. model number or type designation). In addition, consumer products shall be marked with the name and contact address of the manufacturer or Importer (in case the manufacturer is located outside the European Economic Area). Caution: This does not affect the requirement that the License Holder has to be marked in case of licensed products, e.g. GS mark or TUV Rheinland Bauart mark. Hence, and as was already the case under the previous GPSG, if a License holder is the manufacturer acc. to ProdSG and at the same time is located outside the European Economic Area, both markings need to be provided, the name of the License holder (as a certification requirement) and the name and contact address of the Importer (as required by the ProdSG). Due to the fact that often the Importer is not known at the time of certification, the correct labeling of contact information remains the responsibility of the License holder. The contact address is defined as a valid postal address including street, house number, zip code and city. A Internet address or a postal mail box address is not sufficient. New with the ProdSG is the requirement that the name and contact address must now always be applied to the product itself. The exception to mark the packaging instead, is only accepted if labeling of the product itself is not possible or if it would require disproportional effort to do so. Caution: Once the product already carries other markings (e.g. embossing / imprint of a brand name), then the marking of contact information is considered possible! If the product is sold without packaging, then there is anyway no alternative for labeling of the product. The possibility to resort to supporting documents (such as a manual, etc.) is not provided by the ProdSG. Violations of these provisions remained unpunished so far, but since the failure to do so is subject to heavy fines of up to EUR 10,000 per violation. In addition, the authorities are authorized to determine additional fines based on the estimated profits. Version: EN Page 4 of 19

5 3. EMC It is necessary to submit evidence that the product satisfies all applicable EMC requirements. For radiocommunication or telecommunication equipment these requirements are described in the R&TTE Directive (1999/5/EC), for all others refer to the EMC Directive (2004/108/EC). Acceptable evidence to be provided (for all models) are EMC Test reports, Certificates of Conformity, Statement of Opinion from a Notified Body, EMC mark approvals, EMC Declarations or EMC conformity statement within the instructions for use. 4. Acoustic Noise 4.1 Technical work equipment and ready-to-use commodities used in a working environment. These products were previously subject to the 3rd ordinance of the GPSG ("Machine noise information ordinance") which was obsoleted through the Ordinance for the protection of the persons employed from endangerments by noise and vibrations (Lärm- und Vibrationsarbeitsschutzverordnung), dated The responsibility to evaluate these hazards within the working environment lies with the employer, who has to define the protective measures accordingly. 4.2 Household Appliances (airborne noise) This requirement originates from Directive 86/594/EEC on airborne noise emitted by household appliances. 'Household appliance means here any machine, portion of a machine or installation manufactured principally for use in dwellings, including cellars, garages and other outbuildings, in particular household appliances for upkeep, cleaning purposes, preparation and storage of foodstuffs, production and distribution of heat and cold, air conditioning, and other appliances used for non-professional purposes (Article 2(a)). With the coming into force of the "Ordinance for the implementation of EEC Directives 2002/44/EC and 2003/10/EC for the protection of the persons employed from endangerments by noise and vibrations" (LaermVibrationsArbSchV), the ordinance "3.GPSGV" was put out of force on This means that the so far required information in the user instructions of motor operated products that are in the scope of the Low Voltage Directive and which emit noise less than 70dB, is not necessary any more. Nevertheless, if required by the respective applicable Directives or Standards, the evaluation of acoustic noise still needs to be done. Version: EN Page 5 of 19

6 In case the noise level lies above 70dB, the product has to be evaluated individually and information within the user instructions may be required. However, if the acoustic noise level is too high, then the simple information within the user instructions is not sufficient. 4.3 Noise emission in the environment by equipment for use outdoors (2000/14/EC, amended by 2005/88/EC, corrected ) For products falling under Article 12 of the Directive a Notified Body Approval is required. Note: The validity of a "Notified Body Certificate" is usually limited to 1 year during the 1'st year, hence the validity of the GS License will also be limited to 1 year. For products falling under Article 13 of the Directive a self-declaration by the manufacturer can be accepted. Where applicable, the guaranteed sound power level must be marked taking the following form (Example for 104dB): 4.4 GS-mark for IT equipment in combination with Visual Display Units (EK1-ITB 2000) The Testing Principles "EK1-ITB 2000:xxxx" (Basis for GS-mark tests of IT Equipment in Combination with Visual Display Units) comprise requirements that are prerequisites for the safe and ergonomic design of the equipment and implement the requirements of the German Ordinance for work with Visual Display Units (BildscharbV), which is based on the European Council Directive 90/270/EEC "Minimum safety and health requirements for work with display screen equipment". In the scope of EK1-ITB 2000 is IT equipment that is used in combination with Visual Display Units (VDUs) such as Flat Panel Displays, CRTs, Desktop PCs, Keyboards, Notebooks (if in prolonged use at a workstation), Desktop Printers, Desktop Scanners and similar peripheral devices that are used in the direct field of view. The Sound power level L WAd and Sound pressure level L pam (Operation according to manufacturer) acc. to ISO 7779 (ISO 9296) of products with integrated fans and in the scope of EK1-ITB 2000 have to be provided. Version: EN Page 6 of 19

7 5. German law "Food and Feed Code" - LFGB (formerly known as "LMBG") Materials in products that come into contact with food have to be evaluated with regard to the respective requirements of the LFGB. A suitable analysis has to be provided in the test documentation. Evidence from the manufacturer has to be qualified and plausible in order to be acceptable. The information listed below is required : 1. A complete list of materials in contact with food is a) added to the test report (e.g. list of critical components), or b) added as an referenced and uniquely identified appendix to the test report, or c) listed in the CDF which is referenced as appendix to the certificate 2. Compliance with the requirements of the LFGB is declared by the manufacturer, e.g. using the declaration form which can be obtained from TUV Rheinland. This document must be part of the technical documentation. 6. EMF- Electromagnetic fields This requirement applies e.g. to household appliances evaluated according to EN series or lighting equipment acc. to EN There are further EMF standards listed within the Official Journal for the Directive 2006/95/EC "Electrical equipment designed for use within certain voltage limits". Products for which compliance with the requirements is not sure or for which no reference measurement results exist may need to be tested. In this case, the manufacturer has to provide a test report according clause 5 of EN or its successor EN 62233:2008 (DOW ). In case the measurement results are expected to be below the limits (evaluation by engineering judgment or reference table issued by "Bundesamt fur Strahlenschutz" this should be documented in the test report, e.g. by a statement such as: "Additional remarks regarding EMF requirements (EN 50366): Following thorough examination, the electrical field strength (V/m) as well as the magnetic flux density (T) is uncritical for this kind of product. " Refer to and Version: EN Page 7 of 19

8 7. WEEE Directive (2002/96/EC) - Waste Electrical and Electronic Equipment Implemented in Germany through the "Elektro- und Elektronikgerätegesetz - ElektroG" ("Electrical and Electronic Equipment Act") Electrical and electronic equipment placed on the market in an EU Member State after 13. August 2005 must comply this the WEEE Directive. German National law granted a transition period until 23. March The symbol indication separate collection for electrical and electronic equipment consists of the crossed-out wheeled bin, as shown below (refer to Annex IV of the Directive or EN 50419, clause 4.2). The symbol must be printed visibly, legibly and indelibly. Note: The Directive and the EN standard give conflicting information about the marking. As long as this situation exists, it can be assumed that either version can be used. Version: EN Page 8 of 19

9 8. RoHS Directive (2011/65/EU; 2002/95/EC) - - Hazardous substances in electrical and electronic equipment Implemented in Germany through the "Elektro- und Elektronikgerätegesetz - ElektroG" ("Electrical and Electronic Equipment Act") Directive 2002/95/EC as amended by the acts listed in Annex VII, Part A of Directive 2011/65/EU is repealed with effect from 3 January Mandatory from 1'st July, 2006 Prohibited Substances: The placing on the market of new electrical and electronic equipment containing more than 0.1 percent weight of lead, mercury, hexavalent chromium, polybrominated biphenyls (PBBs) or polybrominated diphenyl ethers (PBDEs) per homogeneous substance or more than 0.01 percent weight of cadmium per homogeneous substance is prohibited. (This does not apply to electrical and electronic equipment first placed on the market in an EU Member State prior to 1 July 2006, nor does it apply to spare parts for the repair or re-use of electrical or electronic equipment first placed on the market prior to 1 July 2006.) 9. The validity period of a GS mark license GS mark licenses are valid for a maximum of 5 years (refer to ProdSG 21 (2)), counted from the issue date indicated on page 0001 of the GS license. As of January 1'st 2005, we cannot extend the validity by issuing an additional sheet any more. A new license with a new license number has to be issued for maintaining the validity of the GS mark certification for the product. Each GS license issued on or after January 1'st, 2005 shows the "Latest Expiry Date" in the upper right corner of the license. This date is calculated by "Issue date" (in the left bottom of the license) plus 5 years minus 1 day. Version: EN Page 9 of 19

10 10. Multiple models on GS mark licenses The meaning and purpose of multiple models or suffixes used within type designations have to be documented clearly and sufficient information has to be provided about what the actual, concrete differences between the models are. Fuzzy information such as x = 0-9, A-Z or blank; denoting shipping destination or x = 0-9, A-Z or blank; used for sales purpose or x = 0-9, A-Z or blank; denoting outer appearance cannot be accepted any longer. The following text could be used instead: x = 0-9, A-Z or blank; No constructional differences. Models differ only in model name and marking label or x = 0-9, A-Z or blank; denote different color of decorative back part enclosure. Variables representing ranges, e.g. ranges for power, voltage or current, have to follow the example below : a) all discrete values are mentioned e.g.: x = 12V, 13V, 14.5V, 16V, 18V or b) minimum value - maximum value - step are mentioned. e.g.: y = 50mA - 900mA in steps of 10mA 11. Power Supply Cord Sets included with a GS certified product For products with appliance inlet and a voltage rating that includes AC 230V: The instructions for use must describe the suitable Power Supply Cord Set for Germany, in case it is not provided with the product. For products with non-detachable Power Supply Cord, such a description is not required. Version: EN Page 10 of 19

11 12. Factory inspections The GS mark is a recognised safety mark recognized far beyond the borders of Germany. TUV Rheinland will perform factory inspections regularly during the validity of the GS mark license in order to ensure and control the continuity of the quality and safety relevant parameters of the licensed product. The frequency of the inspections depends on the quality level of the manufacturing facilities, basically once in a year. Prior to the issue of a GS mark license an initial factory inspection need to be performed. In so far as the certified product is produced in several manufacturing plants the inspection is carried out in each factory location. Further details on production control and product related factory inspections are given within general decision "ZEK-GB " of the Central Experience Exchange Circle (ZEK) for the GS mark. The following processes are mainly involved during the factory inspection: check of technical equipment and personnel; verification of manufacturing processes; check of special requirements specific to the product; packaging and operating instructions with regard to the reproduction of the GS mark, printing of model designations, manufacturer identification and postal addresses; check and storage of incoming goods (kind of inspections); production (production line(s), handling of incidental non-conforming parts and products); inspections during production (tests and existence of calibrated measuring equipments); final inspection (tests and existence of calibrated measuring equipments); handling, packaging, storage and shipping of final products; and the existence and application of the working instructions for the processes above. Version: EN Page 11 of 19

12 13. Use of Swiss plug type 11 (2-pole) The Experience Exchange Circle "EK1" has decided on in resolution "07-354Rev.1" and on in resolution "07-352Rev. 1" (partially insulated mains pins), that the issuance of the GS approval for consumer products (e.g. air pump for inflatable air mattress) which are equipped with a Swiss plug type 11 (2-pole, 250V, 10A) and which are destined for the Swiss market is not allowed, even if the test report and the certificate mention the hint Only for use in Switzerland. Reason: It cannot be excluded that the products with Swiss plug may appear on the German market. As the blank pins, when inserted into the receptacle and in contact with hazardous voltage, may be touched with the testfinger, a critical condition is given. The plug can be inserted into a CEE receptacle in such a way that the blank pins can be touched with the testfinger. The safety targets for issuing the GS approval are not fulfilled. Version: EN Page 12 of 19

13 14. Testing and Validation of PAH (in products) in the course of GS-Mark Certification PAH stands for "Polycyclic Aromatic Hydrocarbons" which are chemical substances used in plastic materials to make them soft (e.g. for rubber grips) or as black pigments dye (e.g. enclosures). PAH can also be contained in lacquers, coatings and as preservative for transport and storage. The Central Experience Exchange Circle (ZEK) in connection with the German Accreditation Body for GS Mark issueing Bodies (ZLS), has published document "ZEK : ". Consumer products must comply with legal requirements to avoid health risks, e.g. 30 & 31 of the LFGB, the Restriction of Chemicals act (ChemVerbotsV), and the 3 of the ProdSG (Product Safety Act). With this document and the attached test procedure the requirement regarding PAH in products is substantiated. In addition the test method is harmonized for all GS bodies. The board for technical work equipment and consumer products (AtAV) has decided that the evaluation of PAH for GS certification is mandatory from (GS licensed products certified before had to be evaluated within one year, starting ). Only materials that are accessible without the help of a tool, and such materials which, through a risk analysis, are identified as relevant for PAH testing, need to be included in the evaluation. However, the following steps are to be considered by the GS body for new GS mark certifications as well as in the frame of monitoring existing GS mark licenses : 1. Risk analysis 2. Categorization 3. Test and evaluation The GS body has to perform a Risk analysis and at the same time has to stipulate which (grip) surfaces need to be tested. Basically all (grip) surfaces are to be considered which during intended use or foreseeable misapplication (however not misuse) can be touched or put into the mouth. As the case may be, the risk analysis can be omitted if the Experience Exchange Circles (EK) have already determined a procedure for the product and the product group respectively regarding the (grip) surfaces to be tested. The reference to the EK decision is to be documented accordingly. Depending on the outcome of the Categorization, evidence has to be provided or testing to be conducted respectively. The entire process has to be documented in the framework of GS mark certification. Version: EN Page 13 of 19

14 15. Service offer and Chemical testing Regarding the above mentioned assessment and testing of PAH, LFGB, WEEE & RoHS, TUV Rheinland Group can provide the local services through our branch offices, e.g. within Asia. Local testing on such harmful substances can be accessed through our chemical laboratories. Please contact us for further details. 16. "China Export" (CE) mark rumours Answer given by Mr Verheugen on behalf of the European Commission : The Commission is aware that there exists the misconception attributing CE marking the meaning Chinese export. The Commission is not aware of the existence of a China export mark but considers that the mark the Honourable Member refers to constitute the CE marking as foreseen in the European legislation without, however, respecting the dimensions and proportions prescribed therein. The Commission is aware that CE marking, like any other mark, is misused, e.g. CE marking is affixed to products which do not fulfil the requirements and conditions for its affixing or it is affixed to products for which the affixing is not foreseen. There are also cases where, whilst the product is in compliance with the applicable requirements the CE marking itself does not respect the formal requirements, namely the form of the CE marking or the dimensions and proportions prescribed in the legislation. Version: EN Page 14 of 19

15 17. Labelling of energy-related products The European Community has published a great variety of directives regulating e.g. the labelling of energy-related products (e.g. Electric ovens, air-conditioners, lamps, dishwashers, washer-driers, electric tumble driers, washing machines, electric refrigerators, freezers). Directive 2010/30/EU requires indication by labelling and standard product information of the consumption of energy and other resources. These regulations aim, through the use of energy labels, to provide clear and easily recognisable information for consumers about the energy consumption and performance of products. The most important part of a label is the energy efficiency rating scale which provides a simple index of efficiency, thus enabling consumers to come to an informed purchasing decision. Suppliers are required to provide labels and information notices relating to the energy consumption and certain other performance characteristics, as appropriate, of their products. Dealers must ensure that all products displayed to end-users are appropriately labelled (i.e. the correct label is used and it is attached to the top or front of the product and is not obscured), and that consumers are provided with suppliers information where available. Example: Version: EN Page 15 of 19

16 18. Battery Directive (2006/66/EC, amd. by 2008/103/EC and 2008/12/EC) Effects of the Battery Directive 2006/66/EC, applicable since Sep. 26, 2008, on products : The placing on the European market is prohibited for a) all batteries or accumulators containing more than % of Mercury by weight; and b) portable batteries or accumulators containing more than % of Cadmium by weight. Exceptions for a) apply to button cells, which must not contain more than 2 % of Mercury by weight. For b) following applications are excepted: i) emergency and alarm systems, including emergency lighting; ii) medical equipment; iii) cordless power tools. Furthermore, the batteries or accumulators must be marked with the crossed dust bin without black bar. If batteries, accumulators or button cells contain more than % Mercury, % Cadmium or % lead, the chemical symbols Hg, Cd or Pb shall be added next to the dust bin sign. Last but not least, besides the possibility, that batteries and accumulators must be easily removable by the end-user before disposal of the appliances, additional information to the consumer within the in-struction manual must be provided. Please note, that these requirements need not only to be observed for new testing and certification applications, but also for existing licenses. Version: EN Page 16 of 19

17 19. Dimethyl fumarate (DMF) - Effects on GS certification Prohibition of Dimethyl fumarate (DMF) - Effects on GS certification. Products, which contain the biocide Dimethyl fumarate (DMF), may not be brought in accordance with the decision 2009/251/EC any longer into traffic or made available on the market. The national conversion of the decision took place via the committee for technical media and consumer products (AtAV) and as technical specification was published. For GS Certification the following procedure is applied : The GS Body informs the GS mark applicant on the prohibition of DMF, receives declaration and attaches that evidence to the documentation. If suspicion exists that for the products raw materials were used that contain DMF, proof that the product is DMF free has to be provided and to be documented. (Note: With products, which are manufactured using leather, e.g. leather furniture, protective gloves, protection shoes or - clothes, DMF can already be present in the raw material.) 20. Acceptance of CB Certificates and CB Test Report for GS A CB Test Certificate and CB Test Report submitted as basis for GS certification has to be validated by the GS Body (B) before recognising. It is not necessary for Body B (GS Mark Body) to sub-contract test work to Body A (the originator of the CB Certificate and CB Test Report) when granting a GS Mark, provided that Body B and Body A are recognized NCBs in the CB-Scheme. The responsibility for the completeness, correctness and actuality of the CB Test Report, when taking over from Body A, is placed on the GS Mark Body. The CB Test Report must have been created by a CBTL having the product category in its scope and using either its own laboratory or the TMP procedure (WMT and SMT are not allowed). Version: EN Page 17 of 19

18 21. ECODESIGN Directive (2009/125/EC) Requirements for Ecodesign of energy-related products The Ecodesign Directive (also called ErP Directive), has recasted (reformed) the Directive 2005/32/EC (also called EuP-Directive). The ErP Directive creates a framework for the Regulations of binding requirements for the Ecodesign of products. In many cases, these are requirements for the Energy Consumption and Energy Efficiency in different modes. But also documentation requirements are mandatory to fulfill. The ErP is a CE marking directive, meaning that before a product covered by implementing measures is placed on the market and/or put into service, a CE marking shall be affixed. Depending on the product, the following regulations have to be applied: Regulation No 107/2009 Simple set-top boxes Regulations No 244/2009 and 859/2009 Non-directional household lamps Regulations No 245/2009 and 347/2009 Fluorescent lamps without integrated ballast, for high intensity discharge lamps, and for ballasts and luminaires able to operate such lamps Regulation No 278/2009 external power supplies Regulation No 327/2011 Regulation No 640/2009 Regulation No 641/2009 Regulation No 642/2009 Regulation No 643/2009 Regulation No 1015/2010 Regulation No 1016/2010 No-load condition electric power consumption and average active efficiency of Fans driven by motors with input power between 125W-500kW Electric motors Glandless standalone circulators and glandless circulators integrated in products Televisions Household refrigerating appliances Household washing machines Household dishwashers Regulation No 1275/2008 Standby and off mode electric power consumption of electrical and electronic household and office equipment Status Additional regulations are under development. Version: EN Page 18 of 19

19 Annex 1: Examples of TÜV Rheinland GS marks Version: EN Page 19 of 19