In Romania, ANCOM and ANPC are institutions responsible for the enforcement of the legislation in force in the area of radio equipment and for the radio equipment market surveillance and control activities. ANCOM radio equipment market surveillance and control activity concerns only the conformity of the radio equipment made available on the market and the radio equipment belonging to the end-users –legal persons. ANPC surveillance and control activity concerns only the conformity of the radio equipment belonging to consumers (end-users-natural persons).
Directive on making available on the market of radio equipment
The radio equipment sector is an essential part of the radio communications market, which is a key element of the economy in the European Union. The main directive in this field at EU level is Directive 2014/53/EU
(RED Directive) of the European Parliament and of the Council of 16 April 2014, on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/E
Its purpose is the harmonization of the rules on the marketing and use in the EU of radio equipment that can produce harmful interference, that can generate electromagnetic disturbances, or that may be affected by such disturbances, and which may affect health and /or safety of persons or goods.
All parties directly or indirectly affected by the RED Directive have at their disposal a tool entitled RED Guide
, intended to assist in the interpretation of the RED Directive provisions, but without taking its place. The RED Guide explains and clarifies some of the most important issues related to the Directive’s application and also aims to disseminate widely the explanations and clarifications reached by consensus among Member States and other stakeholders.
This Directive was transposed into Romanian legislation by Government Decision no. 740/2016 on the making available on the market of the radio equipment, which establishes the national regulatory framework for placing/making available on the market, free movement and putting into service as well as using in the Romanian national territory of radio equipment, together with the conformity assessment and marking system.
Market surveillance is a national competence and is intended to make sure that only compliant apparatus is placed on the market. Efficient market surveillance also offers end-users a certain protection and prevents, to some extent, unfair competition.
The European Commission thinks that it will primarily depend on the manufacturers whether the RED Directive becomes a success or not. They need to take responsibility by submitting radio equipment to an appropriate conformity assessment procedure and by placing on the market only compliant apparatus with the provisions of the RED Directive.
Note: Radio equipment subject to Government Decision no. 740/2016 placed on the market until 13 June 2017 and which fulfill the essential requirement provisioned by the Government Decision no. 130/2015 on radio and telecommunications terminal equipment and the mutual recognition of their conformity, may be made available on the market and/or put into service.
The regulatory framework of the RED Directive applies to
The provisions of the RED Directive apply only to the radio equipment as they are defined in article 2 paragraph (1) point 1 and paragraph (2) of the directive.
With the entry into force of RED Directive, radio receivers, designated to be used only for the television/radiobroadcasting, will fall under the scope of this directive and are no longer covered by Directive 2014/30/EU
(EMC Directive). Regarding telecommunications terminal equipment, they cease to be covered by the RED Directive, and fall under the scope of EMC Directive.
There are however certain types of radio equipment that are excluded from the framework of RED Directive, specifically:
- equipment exclusively used for activities concerning national defence, public order and State security, including protection of the economic interests of the State, whether these interests concern the State security, and the activities of the State in the area of criminal law;
- radio equipment used by radio amateurs, unless such equipment is available commercially. The following are considered not being available on the market: radio kits to be assembled and used by radio amateurs, radio equipment modified by radio amateurs for their own use and radio equipment built by radio amateurs, acting individually for scientific and experimental purpose in radio amateurs activity;
- equipment within the scope of Council Directive 96/98/EC of the Council of 20 December 1996 on marine equipment, amended by Directive (EU) 559/2015;
- products, components and appliances in the field of civil aviation, falling within the meaning of Article 3 of Council Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and the establishing of an European Aviation Safety Agency and repealing Directive 91/670/EEC of the Council, Regulation (EC) no. 1592/2002 and Directive 2004/36/EC, with its subsequent amendments;
- assesement kits built to order, for professionals, to be used exclusively in research and development centers for these purposes.
The following basic essential requirements apply to all radio equipment:
- the protection of the health and safety of the persons and pets
, as well as of the goods
including the objectives with respect to safety requirements contained in the Directive 2014/35/EU
of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of Member States relating to making available on the market the electrical equipment designated for use within certain voltage limits, but with no voltage limit applying;
- ensuring an appropriate level of electromagnetic compatibility
, contained in Directive 2014/30/EU
of the European Parliament and of the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to electromagnetic compatibility;
- effective use of radio spectrum and to bear its effective use in order to avoid harmful interference.
Over the Directive 1999/5/EC (Directive R&TTE), Directive 2014/53/EU (RED Directive) introduces at the essential requirement provisioned in article 3 point 2, in addition to the essential requirement of the transmitter on producing no harmful interference, the requirement to provide a performance level of the receiver, so that it can withstand a certain level of the harmful interference.
In addition, the radio equipment that belongs to certain categories or classes shall be so constructed that to be compliant with the following essential requirements:
a) to interact with the accessories, especially with common chargers;
b) to interact with other radio equipment via networks
c) to be connected to interfaces of an appropriate type in the European Union;
d) not to cause any harm to the network or its functioning and not misuse its resources, thus causing an unacceptable degradation of the service;
e) to include safeguards systems to ensure that user’s and subscriber’s personal data and privacy are protected;
f) to have certain features that ensure protection against frauds;
g) to have certain features that ensure access to the emergency services;
h) to have certain features that facilitated its use by persons with disabilities;
i) to have certain features that ensure that a software may be installed in the radio equipment only when the compliance of the whole radio equipment – software was proved.
In accordance with article 3 paragraph (3) of RED Directive, the European Commission is authorized to adopt delegated acts in accordance with article 44 of RED Directive in order to specify what categories or classes of radio equipment are covered by each of the additional essential requirements set out above under letters (a)-(i).
Note: for radio equipment covered by RED Directive will no longer be used by manufacturers in the conformity assessment process of the product with the essential requirements concerning the protection of the health and safety of persons and pets, as well as the protection of goods and ensuring a proper level of the electromagnetic compatibility, the provisions of the Directives 2014/30/EU (EMC Directive) and 2014/35/EU (LVD Directive).
Clarifications regarding the fulfillment of the requirements mentioned in Art. 7 paragraphs (4)-(6) of Government Decision no. 740/2016 on making available on the market of radio equipment
The provisions of Art. 7 paragraph (4) of the Government Decision no. 740/2016 refer to, according to paragraph (1) of the same article, the radio equipment for which the authorisation for putting into service and usage is performed by the National Authority for Management and Regulation in Communications of Romania (ANCOM) with the exception of radio equipment operating in radio frequency bands or radio frequencies exempted from the licensing regime (Decision of the ANCOM President no. 311/2016 on radio frequencies or frequency bands exempted from the licensing regime).
Putting into service and usage of the radio equipment (radiocommunications/broadcasting station) involves the use of limited radio spectrum resources. Thus, based on the Government Emergency Ordinance no. 111/2011 on electronic communications, approved with amendments and completions by Law no. 140/2012, with the subsequent amendments and completions, as well as on the provisions of the Law no. 504/2002 on audio-visual, with the subsequent amendments and completions, radio frequencies can only be used after obtaining the necessary authorisations granted by ANCOM, the exceptions being limited and established by decision of the President of ANCOM.
In relation to authorisations granted for the use of the radio spectrum, the above-mentioned rules are applicable, as the said legal framework serves to authorise the radiocommunications/broadcasting stations used for the provision of electronic communications services or for the provision of broadcasting or television programme services.
Considering the pursued objective of limiting the exposure of the general population to electromagnetic fields, through Art. 4 par. (2) of Government Emergency Ordinance no. 111/2011 the definitions in the Law no. 504/2002 on audio-visual are applicable as well. Under such circumstances, the authorisation of the use of radio frequencies shall also be seen in the context of the Law no. 504/2002 on audio-visual.
The term "documentation", as provided by Art. 7 par. (4) of the Government Decision no. 740/2016, means documenting the results of the technical measurements carried out to verify the fulfillment of the essential requirement referred to in Art. 3 par. (1) letter a) of the Government Decision no. 740/2016, including technical measurements of non-ionizing electromagnetic radiations (e.g. measurements relating to the determination of the power density of the electromagnetic field or the intensity of the electromagnetic field, specifying their values).
The updating of the documentation provided by Art. 7 par. (6) of the Government Decision no. 740/2016 means adding to the abovementioned initial documentation the technical measurements resulting from periodic re-checks.
Since the measures imposed by Art. 7 paragraphs (4)-(6) of the Government Decision no. 740/2016 concern the essential requirement referred to in Art. 3 par. (1) letter a) of the same normative act and, therefore, are directly related to the limitation of the exposure of the general population to electromagnetic fields, we conclude that the established requirements do not overlap with the conditions for putting into service and usage of the radiocommunications/broadcasting station according to the technical and operational parameters of the radio frequencies usage license/broadcasting license or of the frequencies assignment authorisation/technical authorisation for operation.
The technical measurements referred to above will be presented as a document signed either by the holder of the radio frequencies usage license/broadcasting license, if the said holder carried out the measurements on his own, or in the name and on behalf of the holder, by the third party that carried out the measurements. The document shall include at least the following elements:
- radiocommunication/broadcasting station location data (geographic coordinates, postal address, building, pole etc.);
- date of measurement;
- measuring equipment (name, manufacturer, type and series);
- value/values determined by the measurements;
- the conditions under which the measurements were made (geographic coordinates of the place/places of measurement, measured frequencies range, environmental conditions: temperature, humidity).
Additional information on performing non-ionizing electromagnetic radiation measurements are available in the ECC/REC(02)04 Recommendation - Measuring non-ionizing electromagnetic radiation (9 kHz - 300 GHz), available at http://www.erodocdb.dk.
According to the provisions of Art. 7 paragraphs (4)-(6) of the Government Decision no. 740/2016, the putting into service and usage of any radiocommunications/broadcasting station have to take into account the compliance with the essential requirement referred to in Art. 3 paragraph (1) letter a) of the aforementioned normative act, namely "the protection of health and safety of persons and of domestic animals and the protection of property including the objectives with respect to safety requirements set out in the Government Decision no. 409/2016, but with no voltage limit applying."
If the measured electromagnetic emission levels exceed the limit values set out in the normative acts in force (Norms for limiting the exposure of the general population to electromagnetic fields from 0 Hz to 300 GHz, approved by the Order of the Minister of Public Health No. 1193/2006 published in Romania's Official Gazette, Part I, No. 895 of 3 November 2006), the holder of the radio frequencies usage license/broadcasting license will apply specific measures to remain within the legal limits.
Radio equipment classes under Directive 2014/53/EU
Pursuant to article 8 paragraph (2) of the RED Directive, the European Commission adopted implementing acts to establish the equivalence of notified radio interface and to assign a class of radio equipment, the details of which are published in the Official Journal of the European Union. Thus the system of radio and telecommunications terminal equipment classification (Class 1 and Class 2) provisioned in Directive 1999/5/EC was dismissed.
Conformity of radio equipment – software combination
Directive 2014/53/EU introduces a new element, that for the radio equipment with an installed software the manufacturers shall asses the conformity of the radio equipment - software combination with the essential requirements of the directive. The European Commission is authorized to adopt delegated acts in accordance with article 44 of RED Directive in order to specify what categories or classes of radio equipment are covered by this requirement.
Registering the types of radio equipment belonging to certain categories
As of 12 June 2018, manufacturers are required to register in a system that will be made available by the European Commission, the types of radio equipment that will belong to certain categories of radio equipment that will present a low level of compliance with the essential requirements of RED Directive. The European Commission is authorized to adopt delegated acts in accordance with article 44 of directive in order to specify what categories of radio equipment are covered by this requirement.
The conformity assessment process for radio equipment covered by Directive 2014/53/EU lies in one of the following conformity assessment procedures: internal production control, EU type examination followed by type conformity assessment based on internal production controlor conformity based on full-quality assurance, made by the manufacturer. This process entails ensuring that radio equipment are in accordance with the requirements specified in article 3 of the Directive.
The manufacturer may choose to follow one of three conformity assessment procedures referred to above. If, in the process of conformity assessment of radio equipment with the essential requirements set out in article 3 paragraphs (2) and (3), the manufacturer has not applied or has only partially applied harmonized standards whose references have been published in the Official Journal of the European Union or where such harmonized standards do not exist, the manufacturer has the obligation to choose between the following two conformity assessment procedures: EU type examination followed by type conformity assessment based on internal production controlor conformity based on full-quality assurance.
If the manufacturer chooses EU type examination followed by type conformity assessment based on internal production control, this procedure requires that the manufacturer must appeal to a notified body to assess compliance of radio equipment based on the relevant technical documentation of the equipment. After examining the technical documentation by the notified body, this may issue an EU-type examination certificate to the manufacturer, proving that the quipment meets the essential requirements set out in article 3. This certificate will be attached, then, to technical documentation. The manufacturer shall keep the technical documentation relating to the product, ten years after it was placed on the market. Also, the importer must ensure that the manufacturer has drawn up the appropriate technical documentation and that the technical documentation can be made available to ANCOM upon request.
If the manufacturer chooses conformity based on full-quality assurance, this means that the manufacturer will use a quality system approved for the design, manufacture, final inspection of finite radio equipment and for technical tests of radio equipment in question, in order to prove the compliance of radio equipment with the essential requirements set out in art. 3 of the Directive. The quality system is assessed by a notified body.
Details concerning these three conformity assessment procedures are set out in Annexes 2, 3 and 4 of RED Directive RED (Annexes 2, 3 and 4 to Government Decision no.740/2016).
After completion of the conformity assessment process, the manufacturer or his authorized representative in the EU can affix the EC marking on radio equipment. Affixing must comply with the instructions described in the article 19 and 20 of RED Directive (article 21 of Government Decision no. 740/2016).
The presence of EC marking on equipment covered by RED Directive on the making available on the market of radio equipment is a clue that they meet the technical requirements in force in order to be sold anywhere in the European Economic Area – EEA, as well as in Turkey. EC marking applies to products manufactured in the third countries.
The European Commission has launched a one-stop web portal with all the information about the EC marking.
Harmonised European Standards
The use of harmonised standards is provided in art. 16 of RED Directive. Commission entrusted a mandate to European standardization bodies (ETSI, CEN, CENELEC) for the development of a set of harmonised standards.
When references of harmonised standards are published in the Official Journal of the European Union, when a manufacturer declares that his/her product complies with the applicable harmonised standards, he/she benefits from "the presumption of conformity" of that product with the essential requirements specified in the RED Directive.
Therefore, the first step that a manufacturer should take in order to ensure that a radio equipment will comply with the provisions of the RED Directive is to verify which European harmonised standards are applicable.
The European Commission makes available a list
of harmonised standards related to radio equipment. It is worth mentioning that the use of harmonised standards is voluntary.
Notified Bodies (NB)
The Notified Bodies (NB) fulfil the tasks listed under Chapter IV of the Government Decision no. 740/2016.
of the Notified Bodies, notified in the European Union in accordance with the RED Directive