ENTERPRISE DIRECTORATE-GENERAL
Conformity and standardisation, new approach, industries under new approach
Mechanical and electrical equipment (including telecom terminal equipment)
TCAM Secretariat
Brussels, 12 February, 2009
Ref: (15)01 Agenda TCAM 15.doc
DG ENTR G3
TCAM 3 (09) 16 Rev. 15
Status discussion legal issues
The following table reflects the state of discussion on the legal issues.
Description / Introducing document / Status1.Ambiguity in Annex III of the Directive
/ TCAM 2 (99) 36 / Concluded in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM 2: SF, SV, NL, FR (agreement).Conclusion: Manufacturers, when using annex III are not required to affix a notified body number if they use the essential radio tests of a harmonised standard.
2.Application of Article 6.4 to receivers and discussion on the scope of equipment to be notified
/ TCAM 2 (99) 36 / First discussion in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, SV, NL, FR (agreement).Issue for discussion in Workshop 13 September 1999 (TCAM 3 (99) 13).
Conclusion: Exemption of receivers can only be achieved through an appropriate definition of the term for “harmonised frequencies, the use of which is harmonised throughout the Community”. Such an appropriate definition was discussed in TCAM 3, where a definition was agreed, which includes receivers (Decision 16)
3.Clarification of the relation of the R&TTE Directive with the EMC and LVD Directives
/ TCAM 2 (99) 36 / Issue clarified by the Commission in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, SV, NL, (agreement), FR (partial agreement, certain issues unresolved)Conclusion:
- Standards remain to be mandated and produced under the EMC and LVD Directives;
- In order to give a presumption of conformity the references however have to be published under the R&TTE Directive;
- Article 10.5 is retained for aeronautical equipment.
4.Interpretation of article 6.3 for equipment, the use of which is harmonised in the Community
/ TCAM 2 (99) 36 / Issue clarified by the Commission in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, SV, NL, FR (agreement)Conclusion: manufacturers should indicate where receiving equipment is intended to be used. For receiving equipment, which is not allowed to be used for other reasons then those covered by the Directive (e.g. radar-warning apparatus), he should in general terms indicate, that usage may be constrained.
5.Can an equipment identifier be empty?
/ TCAM 2 (99) 36 / Issue clarified by the Commission in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, SV, NL, FR (agreement)Conclusion: it is possible to have an empty equipment identifier
6.Application of article 9.5 of the Directive to receive-only equipment
/ TCAM 2 (99) 36 / Issue clarified by the Commission in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, SV, NL, FR (agreement)Conclusion: Member States cannot invoke article 9.5 to bar receive-only equipment from their market
7.Application of Annex IV when radio equipment complies with harmonised standards for Art.3.2 but not for other essential requirements
/ TCAM 2 (99) 36 / First discussion in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, (only apply annex IV when no harmonised standards are used for radio parameters) NL, FR (needs further assessment), SV (Annex IV to be applied also when HS not used for other then radio parameters). Discussion concluded in TCAM 3:Conclusion: In the absence of a harmonised standard annex IV has to be used. This also applies for those requirements covered by article 3.1.a and 3.1.b of the Directive. Member States are urged to implement the Directive so that essential radio test suites would only relate to article 3.2 requirements and not to articles 3.1 or 3.3 requirements and pointed out that manufacturers could also use annex V of the Directive (Decision 3.8).
8.Possibility for Member States to introduce requirements to enable interception of calls
/ TCAM 2 (99) 36 / Issue clarified by the Commission in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, NL (agreement)Conclusion:
- Member States could invoke article 30 in such cases, subject to being able to demonstrate that the measure is necessary and proportional to achieve the objective.
9.Possibility to place products on the market in the Community, which cannot be used in the Community
/ TCAM 2 (99) 2 Art.6 / First discussion in TCAM 2 (TCAM 3 (99) 3). Discussion concluded in TCAM 3 (Decision 9).Conclusion:
TCAM endorses the interpretation of the Commission that radio equipment, which is not intended for use in the Community can be marketed, provided that the manufacturer abides by the rules of the Directive as regards marking, information to the user and notification to spectrum authorities.
10.Clarification on transitional arrangements, seizure of type approval certificates
/ TCAM 2 (99) 33 / First discussion in TCAM 2 (TCAM 3 (99) 3).. MS that commented after TCAM 2: SV (approval and placing on the market until 8/4/2001). Issue clarified by the Commission in TCAM 3 (Decision 10).Conclusion:
8/4/2000: conformity assessment and placing on the market only possible under existing national approval regimes or under 98/13/EC.
>=8/4/2000 and <8/4/2001: conformity assessment only possible under 1999/5/EC. placing on the market for the first time possible on conformity assessment under 1999/5/EC and alternatively existing approval regimes
>=8/4/2001: conformity assessment and placing on the market for the first time only possible under 1999/5/EC
11.Interface publication for innovative services, possibility for Member States to position an NTP at the user side of the terminal
/ TCAM 2 (99) 37 / Issue introduced in TCAM 2 (TCAM 3 (99) 3). Issue clarified by the Commission in TCAM 3 (Decision 11).Conclusion:
NRAs can within their discretion decide that publication of interfaces of innovative services could be done immediately before service offering. It is not possible to exempt operators from their obligations under article 4.2 and it is thus not possible to place the NTP at the user interface with terminal equipment.
12.Limitations, posed by WTO obligations and obligations of Member States under article 28 of the Treaty on the possibility for Member States to regulate interfaces
/ TCAM 2 (99) 26 / Issue introduced in TCAM 2 (TCAM 3 (99) 3). Issue clarified by the Commission in TCAM 3 (Decision 12).Conclusion:
No general rules can be defined justifying spectrum regulation. “Efficient use of the spectrum” and “avoidance of harmful interference” are valid reasons for spectrum regulation but that there may be other public interest reasons.
13.What notified body number is to be affixed if more than one notified body is involved (Annex IV, or a different notified body is involved for annex III and Annex IV)
/ TCAM 3 (99) 14 / Issue clarified by the Commission in TCAM 3 (Decision 13).Conclusion:
The numbers of all notified bodies, which are involved in the conformity assessment procedures need to be affixed.
14.Clarification of Manufacturers, representatives or persons responsible for placing on the market
/ TCAM 3 (99) 14 (Example 1,Example 2) / Issue clarified by the Commission in TCAM 3 (Decision 14).
Conclusion:
The tasks of a manufacturer fall on an importer, where that importer has affixed the CE mark on a product.
15.Notification to the Member States of non-harmonised radio products
/ TCAM 3 (99) 14 / Issue clarified by the Commission in TCAM 3 (Decision 16). Follow-up issue under 20.Conclusion:
Notification under Article 6 (4) of Directive 1999/5/EC is required for equipment covered by the following definition: Radio equipment which uses frequency bands whose use is not harmonised throughout the European Union. This is considered to be all radio equipment except those:
- which do not transmit; or
- which can only transmit under the control of a network or otherwise automatically adapts without user intervention so as to never harmfully interfere wherever deployed in the EU; or
- which transmit exclusively in frequency band(s) which are allocated to the same radio interface in every MemberState in the following way:
b)within this allocation, the allotment and/or assignment of radio frequencies or radio frequency channels follows a common plan or arrangement; and
c)the equipment satisfies common parameters (e.g. frequency, power, duty cycle, bandwidth, etc.).
Notification of radio equipment which uses frequency bands whose use is not harmonised throughout the Community should be made to relevant Member States, i.e. Member States upon whose market it is intended to place the equipment.
16.Interpretation of article 12.3
/ TCAM 3 (99) 14 / Issue clarified by the Commission in TCAM 3 (TCAM 3 (99) 42 Ch.8).Conclusion:
Member States have the obligation to ensure that action be taken against ill marked equipment. Article 12.3 has to be read in conjunction with article 9.1. In this context Member States also have to take account of their obligations under article 10 EC.
17.Liability of the signatory of a declaration of conformity
/ Issue clarified by the Commission in TCAM 4, (TCAM 4 (99) 43 §1)Conclusion:
Only in exceptional cases would the signatory of a declaration of conformity be liable for wrongly signing a declaration of conformity. In first instance the company would be liable..
18.Committee procedure to be used when consulting TCAM on the appropriateness of a national application of article 9.5
/ Issue clarified by the Commission in TCAM 4 (TCAM 4 (99) 43 §2)Conclusion:
The consultation is purely informal, as the opinion is not related to a Commission Decision. Therefore neither the consultative nor the regulatory Committee procedures apply.
19.Publication obligations of operators, which already offer services
/ Issue clarified by the Commission in TCAM 4 (TCAM 4 (99) 43 §3)Conclusion:
Operators, which already offer services have to publish their interfaces by 8 April 2000.
20.Interpretation of the term “relevant MemberState” in article 6.4 of Directive 1999/5/EC
/ TCAM 4 (99) 13 / Follow-up issue from 15. Issue clarified by the Commission in TCAM 4.Conclusion:
The majority interpretation given in TCAM 3 (See Decision3.16) is compatible with article 6.4: Member States upon whose market it is intended to place the equipment but where the equipment is not complying with the national frequency use.
An interpretation, which would also request notification of equipment, which complies with the national frequency use is however not incompatible with article 6.4
21.Obligation of manufacturers to include their name as part of the marking under article 12.4
/ Issue clarified by the Commission in TCAM 4 (TCAM 4 (99) 43 §6)Conclusion:
The name of the manufacturer (i.e. the entity taking responsibility for compliance with the Directive) needs to be put on the equipment
22.Procedure to use for the notification of interface regulations, application of Directive 98/34/EC
/ TCAM 2 (99) 2, / First discussion TCAM 5 (TCAM 5 (00) 31 #1). Commission stated its position. Certain Member States considered that notification wasn't required under Directive 98/34/EC. Issue concluded in TCAM 6, where delegations supported the position of the Commission that, where national interface regulations define technical requirements, which products have to meet in order to be used, their drafts need to be notified under Directive 98/34/EC. Otherwise they need to be notified under Article 4.1 of the R&TTE Directive.23.Coverage of components by the R&TTE Directive, example of blinking antennas
/ TCAM 5 (00) 31 Annex 1 / Discussion concluded in TCAM 5 (TCAM 5 (00) 31 #2).Conclusion: Such components affect the characteristics of the transmitter on which they are to be mounted and therefore potentially affect the compliance with the Directive. They are covered by the Directive and therefore need to comply with its provisions (Decision 5.2).
24.Form of the manufacturers' declaration to be put into the users manual
/ A first discussion took place in TCAM 5 (TCAM 5(00) 31 #3). Discussion concluded through written procedure in June 2000 (TCAM 6 (00) 30).Conclusion:
A compromise was found to satisfy the requirement of the Directive that a declaration of conformity is available to the user in a language he understands, whilst not forcing the manufacturer to have to include a copy of the original Declaration of Conformity. The manufacturer makes an informal statement of conformity in the manual in the languages of the Community, whilst he either includes the original DoC or informs the user on where this can be found.
25.Interface publications vs. essential requirements
/ Issue was clarified in TCAM 5 (TCAM 5 (00) 31 #4).Conclusion:
Operators should only provide a declaration on those elements, which are under their control. Telecommunication operators only need to publish the technical characteristics of their interfaces. There may be requirements, which are beyond the control of the operator, for which he is not in a position to provide them. Network operators however need to inform the manufacturer about the safety situation in networks, so that they can take that into account when designing products.
26.Requirements products need to meet, which are only sold over the Internet
/ Issue clarified in TCAM 5 (TCAM 5 (00) 31 #5)Conclusion:
Equipment sold through the Internet into the EU needs to comply with the Directive. Problems however occur with the enforcement of this obligation on non-EU commercial entities.
27.Equipment within the scope of article 1.5: do they need to be notified under 3052/95? Do Member States have to exempt them from the Directive?
/ Issue clarified in TCAM 5 (TCAM 5 (00) 31 #6)Conclusion:
Member States are not obliged to exempt such equipment from the Directive. Only equipment factually banned from being placed on the market should be notified under Decision 3052/95.
28.Can Member States regulate the technology of infrastructure and put into place a type approval note.
/ Issue clarified in TCAM 5 (TCAM 5 (00) 31 #7)Conclusion:
In principle, given that the R&TTE Directive does not regulate such equipment Member States are free to continue/introduce this type of legislation. Such legislation is however not in the spirit of the Directive and potentially a disproportionate barrier to trade.
29.Compatibility of ERC Decisions on license exemption for radio terminals with the R&TTE Directive
/ First discussion in TCAM 5 (TCAM 5 (00) 31 #8). Commission presented its position in TCAM 6. Commission to discuss an appropriate way forward with the ERC. Commission wrote a document to the ERC for discussion in ERC Plenary (TCAM 8 (00) 6) , which referred the matter back to the working groups to respond to Action6.7. Matter touched upon again in TCAM 8. Issue finally closed in TCAM 9 noting the Commission position.30.What kinds of aeronautical equipment does the Directive cover?
/ Issue clarified in TCAM 5 (TCAM 5 (00) 31 #9).Conclusion:
ATMS equipment is excluded from the scope of the Directive and therefore potentially covered by national regulations. It needs to be studied, whether this poses a problem and whether it is desirable to include them when reviewing the Directive.
31.Are Radars covered by the Directive?
/ Issue clarified in TCAM 5 (TCAM 5 (00) 31 #10).Conclusion:
Radars are covered by the Directive
32.When do Commission Decisions have to be applied?
/ Issue clarified in TCAM 5 (TCAM 5 (00) 31 #11).Conclusion:
Commission Decisions have to be applied as of the date of notification to the MemberState. Where such would cause problems, appropriate interim periods could be build into such Decisions.
33.Conformity assessment procedures and relation with EMC and LVD
/ Continuation of issue 3. First discussion in TCAM 5Conclusion:
- Article 10.5 of the EMC Directive did not further apply to equipment within the scope of the R&TTE Directive.
34.Declarations of Conformity for equipment within the scope of the R&TTE Directive
/ The matter was discussed in TCAM 6. Matter to be finalised through e-mail (Action 6.8). Discussion in TCAM 7 demonstrated diverging views. Commission to draft a ‘modus vivendi’ proposal for TCAM8 (action7.4). This proposal (TCAM 8 (01) 30) was supported by delegations in TCAM 8.Conclusion:
Noting the fact that the conformance to the essential requirements of article 3.2 and 3.3 can only be declared against the R&TTE Directive it is agreed to:
- Leave it to the manufacturer to declare in the original DoC the conformance of a product to the requirements of article 3.1.a (electrical safety) and article 3.1.b (EMC) either against the EMC resp. Low Voltage Directive or the R&TTE Directive.
- Insist on the reference to the R&TTE Directive in the user documentation
35.Clarification on information, which could be requested in an article 6.4 notification
/ The matter was concluded in TCAM 6 (TCAM 6 (00) 49 #2), where Member States shared the analysis of the Commission:Member States shall require manufacturers, in the context of article 6.4, only to notify information on the intentional transmissions of radio products.
They cannot therefore request manufacturers to notify the following types of information, which have been found in the forms of certain Member States:
- information related to compliance with the essential requirements of the Directive: compliance with the essential requirements is ensured through the conformity assessment procedures and any problems are to be handled through the safeguard procedures of the Directive;
- a statement of compliance with certain standards: compliance with standards isn't mandatory and therefore cannot be required;
- Information on where equipment will be marketed: such information isn't relevant for a national authority. The only information, which is relevant in this context is information on areas, for which usage is intended.
36.Conformity assessment procedures to be followed for low power radio transmitters which don't risk to cause safety problems
/ Discussion concluded in TCAM 6. Conclusion that the issue cannot be resolved in the current legal framework and that therefore the situation can only be resolved in the review or by the adoption of a suitable harmonised standard.37.Exclusion of broadcast receivers and ambiguities caused
/ Discussion concluded in TCAM 6 (Decision 6.10). TCAM shared the position of the Commission that receivers, capable of listening into both broadcasting and other bands are covered by both the EMC and LVD for their functioning in broadcasting bands and the R&TTE Directive for the other bands38.Limitation of use of receivers and classification of receivers as class 1
/ Discussion concluded during TCAM 6. TCAM supported the analysis of the Commission that receivers, for whom the usage or marketing is restricted, can remain within class 1.39.Components, antennas, borderline of coverage of the Directive
/ First discussion in TCAM 6. Whilst TCAM agrees that normally antennas are covered by the Directive, it would be disproportionate to have simple antennas, e.g. GSM replacement antennas covered by the Directive. Further thinking is required as to how to achieve this. TCAM 7 rediscussed the matter and requested ADCO and RR11 to further study the issue (Action 7.3) and formulate a proposal for discussion in TCAM 8. Their conclusions (TCAM 8 (01) 51) were endorsed by TCAM 8.Conclusion:
1Antennas may be subdivided into "active" and "passive" types. In this categorisation, an "active" antenna is one that, as supplied, includes one or more electronic components interacting with the signal. All other antennas are in principle considered "passive", irrespective of gain or directional properties.
2Active antennas are relevant components under Article 2(c) of the RTTE Directive, and thus are subject to the full requirements of the Directive if placed on the market as a single commercial unit for distribution or final use.
3Passive antennas are not considered as relevant components in their own right under Article 2(c) of the RTTE Directive, and thus fall outside the scope of the RTTE Directive if placed on the market as a single commercial unit for distribution or final use. Passive antennas, if they are marketed in conjunction with a radio product, will be subject to all the requirements of the Directive as part of the overall radio product.
4Manufacturers who place on the market radio products without an antenna or with an antenna which is intended to allow replacement have a responsibility to provide information on the general types and/or characteristics of antennas that may be used with their equipment in order that the overall radio equipment will remain compliant.
5Manufacturers of antennas are under an obligation, including through consumer laws, to ensure their products are fit for purpose. This requires manufacturers, where the relevant ETSI harmonised standards include antenna requirements (for instance antenna radiation pattern for point to point systems) or where the manufacturer of the intended radio equipment has provided information on the types and characteristics of antennas suitable for his radio product, to ensure that these requirements are met.
6Where a radio system is integrated on site - as for microwave point to point and point to multi-point systems - the system integrator is responsible for ensuring compliance of the system with the Directive when the system is brought into service.
7The above guidance takes into account that in practice there is a low risk of harm to people or of harmful interference resulting from the separate sale of passive antennas, and that it would be disproportionate to consider them as relevant components. However, in exceptional cases, TCAM can decide that an a priori passive antenna can nevertheless be treated as "active" when it is possible to identify a reasonable risk that failure to meet the essential requirements of the Directive will result from its use.
In TCAM 17 the matter was again raised in the context of a specific standard. No discussion in TCAM 18, TCAM19 concluded:
Noting that:
1)item 7 of the TCAM Guidance on antennas states “The above guidance takes into account that in practice there is a low risk of harm to people or of harmful interference resulting from the separate sale of passive antennas, and that it would be disproportionate to consider them as relevant components. However, in exceptional cases, TCAM can decide that an a priori passive antenna can nevertheless be treated as "active" when it is possible to identify a reasonable risk that failure to meet the essential requirements of the Directive will result from its use.”
AND that:
2)draft ETSI EN 302 217-4-2 V1.1.2 “Fixed Radio Systems; Characteristics and requirements for point-to-point equipment and antennas; Part 4-2: Harmonized EN covering essential requirements of Article 3.2 of R&TTE Directive for antennas” seeks to impose Article 3.2 requirements on separately supplied antennas intended for use in fixed radio systems within the scope of the standard;
TCAM is of the opinion that there is a reasonable risk of failure to meet the essential requirements of the Directive if such antennas are not considered “active” in the sense of the guidance and decides that:
separately supplied antennas intended for use in fixed radio systems within the scope of candidate harmonised standard ETSI EN 302 217-4-2 V1.1.2 are “relevant components” in the meaning of Directive 1999/5/EC and that the candidate harmonised standard should be prepared accordingly.
40.Is there a need for a manufacturer to have an EU representative when notifying under article6.4.