Law 3/1985, of March 18, of Metrology, establishes the legal regime of the metrological activity in Spain, to which they must submit in defense of the safety, the protection of the health and the economic interests of the consumers and users of the measuring instruments under the conditions which they are determined to determine. This Law was subsequently developed by various norms of metrological content, among which is the Royal Decree 889/2006, of July 21, which regulates the metrological control of the State on measuring instruments.

Commission Regulation (EC) No 37/2005 of 12 January 2005 on the control of temperatures in the means of transport and the storage and storage premises of ultra-frozen food intended for consumption (a) to determine that the means of transport and the storage and storage of deep-frozen foodstuffs must be provided with adequate recording instruments to monitor regular and frequent intervals of air temperature; which are subjected to deep-frozen foods. The same regulation specifies that all the above measuring instruments used to control the temperature must comply with EN 12830, EN 13485 and EN 13486, while repealing Directive 92 /1/EEC.

On the other hand, Royal Decree 380/1993 of 12 March 1993 on ultra-frozen foodstuffs intended for human consumption provides that the means of transport and storage and storage facilities must be provided for during the use of appropriate recording instruments to monitor, automatically and at regular and frequent intervals, the air temperature to which the ultra-frozen food intended for human consumption is subjected. In the case of transport, measuring instruments shall comply with the provisions of the State legislation on metrological control or, where appropriate, the legislation of the country in which the means of transport are registered, the reason why the Spanish State issued the Order of the Ministry of Public Works of 2 September 1996 regulating the State's metrological control over temperature recorders in the transport of ultra-frozen products for the human consumption.

It should be noted, in turn, that in point 6 of Article 5 of Royal Decree 237/2000 of 18 February laying down the technical specifications to be met by special vehicles for the transport of goods by land food products at regulated temperature and the procedures for the control in accordance with the specifications, indicate that they will have an obligation to install an appropriate measuring and recording device for the inside temperature of the box, vehicles of the RRC, FRC and FRF classes, when they carry out transport of deep-frozen products other than local distribution.

For all of the above, it is necessary that, from the metrological point of view, at least the requirements that must be met in order to overcome the metrological control of the State are regulated these instruments used in the means of transport and local storage and storage of deep-frozen food intended for human consumption.

For the elaboration of the order, the autonomous communities have been consulted and the mandatory hearing has been carried out for the interested parties. He has also favourably reported the Metrology Board.

This provision has been submitted to the procedure for information on technical standards and regulations, provided for in Directive 98 /34/EC of the European Parliament and of the Council of 22 June, as amended by the Directive 98 /48/EC of 20 July and by Royal Decree 1337/1999 of 31 July, which incorporates both directives into the Spanish legal order.

In its virtue, I have:

CHAPTER I

General provisions

Article 1. Object.

The purpose of this order is to regulate the metrological control of the State of temperature recorders and thermometers, as well as of the dissociable sensors thereof, to be installed or used in the transport, storage, distribution and control of products at controlled temperature, in compliance with regulatory provisions.

Article 2. Metrological control phases.

The metrological control of the State established in this order is the one that is regulated in Chapters II and III of Royal Decree 889/2006, of 21 July, which regulates the metrological control of the State on measuring instruments which relate, respectively, to the marketing and putting into service stages and to the instruments in service of the measuring devices referred to in Article 1 of this order.

The control set out in Chapter II shall be carried out in accordance with the conformity assessment procedures set out in Article 6 and Annex III to Royal Decree 889/2006 of 21 July 2006.

The controls of the instruments that are in service will comprise both after-repair or modification verification and periodic verification of those.

CHAPTER II

Marketing and commissioning phase

Article 3. Essential metrological and technical requirements.

The essential, metrological and technical requirements to be met by the instruments are those identified in the technical documents listed in Annex III of this order.

Article 4. Modules for conformity assessment.

The modules to be used to carry out the conformity assessment of the instruments referred to in Articles 1 and 2 of this order shall be chosen, including those laid down in Article 6 (2). of Royal Decree 889/2006 of 21 July 2006, and which are developed in Annex III, by the person responsible for putting them into service, by combining one of the following options with their choice:

a) Module B, model examination, plus module D, declaration of conformity to the model, based on the quality assurance of the manufacturing process.

b) Module B, model examination, plus Module F, declaration of compliance with the model based on product verification.

c) Module G, compliance statement based on unit verification.

The tests for the Modules B, F and G are defined in Annex I of this order.

The conformity with the essential metrological and technical requirements, as laid down in Article 3, of those instruments from other Member States of the European Union and Turkey or originating in other Member States is assumed. States which are signatories to the Agreement on the European Economic Area, which comply with the technical standards, rules or procedures legally established in these States, or have received a certificate from these bodies, provided the levels of accuracy, safety, suitability and suitability are equivalent to those required in this order.

The competent public administration may request the necessary documentation to determine the equivalence referred to in the preceding paragraph. Where the non-compliance with the essential, technical and metrological requirements is established, the competent public administration may prevent the placing on the market and service of the instruments.

CHAPTER III

Verification after repair or modification

Article 5. Definition.

It is understood by verification after repair or modification, in accordance with the provisions of Article 2 (z) of Royal Decree 889/2006, of July 21, the set of administrative, visual and technical examinations which may be carried out in a laboratory or in the place of use, which are intended to check and confirm that an instrument in service maintains, after a repair or modification requiring the breaking of seals, the characteristics the metrological nature of the application, in particular as regards the maximum permissible errors, as well as works according to its design and in accordance with its specific regulations and, where applicable, the approved design or model.

Article 6. Performances of the repairers.

All the actions performed by an authorized repairer will be documented in a work part, in a self-copying diptych format. The first sheet of the part shall be held by the repairer and the second sheet, held by the holder of the temperature recorder or the thermometer, both at the disposal of the competent authority and of the approved bodies of the verification, for a minimum period of two years after the intervention was made.

The nature of the repair, the replaced elements, the date of the action, the number with which the repairer who has made the repair is registered in the Metrological Control Register, the identification of the person who has made the repair or modification, his signature and the stamp of the repairer. The description of the operations carried out shall be sufficiently detailed so that their scope can be assessed by the competent authority.

Article 7. Bound subjects and requests.

The holder of the thermometer or temperature recorder shall inform the competent public administration of its repair or modification, indicating the object of the repair or modification and specifying the substituted elements in its case, and the adjustments and controls carried out. Before it is put into service, it shall ask the competent public authority or the verification body for verification.

The application for verification shall be submitted by completing the bulletin set out in Annex II.

Once the application for verification of a thermometer or temperature recorder has been submitted after repair or modification, the competent public administration or the authorised metrological verification body they shall have a maximum period of 30 days for verification.

Article 8. Testing and execution.

The instrument must pass an administrative examination, consisting of the complete identification of the instrument and the verification that it meets the requirements required to be legally in service. It shall be carried out on the basis of the information in the identification bulletin referred to in Annex II. It shall be determined in particular that the instrument has the declaration of conformity or, where appropriate, the approval of the model, and the corresponding markings in accordance with the provisions of Royal Decree 889/2006 of 21 July 2006, and that the characteristics meet the requirements stated in each case.

The tests to be performed for verification after repair or modification are the same as those required for periodic verification.

Article 9. Maximum errors allowed.

The maximum allowable errors are those listed in Annex III.

Article 10. Compliance.

After the verification phase after repair or modification, the conformity of the thermometer or the temperature recorder to perform its function shall be recorded by the adhesion of a label in a visible place. of the verified instrument, which shall meet the characteristics and requirements set out in Annex I to Royal Decree 889/2006 of 21 July 2006, specifying in that instrument the class of instrument concerned. The corresponding certificate of verification shall also be issued. The verifier shall reseal the instrument.

The verification after repair or modification shall have periodic verification effects with respect to the calculation of the time limit for the application of the deadline.

Article 11. Not exceeding verification.

When a thermometer or temperature recorder does not exceed the verification after repair or modification, it must be put out of service until the deficiency that has prevented the exceeding is remedied. This circumstance shall be made by means of a disable label for use, situated in a visible place of the instrument, the characteristics of which are set out in Annex I to Royal Decree 889/2006 of 21 July 2006, specifying the class of the instrument concerned. In the event that such a deficiency is not remedied, appropriate measures shall be taken to ensure that it is definitively withdrawn from the service.

CHAPTER IV

Periodic Verification

Article 12. Definition.

It is understood by periodic verification, in accordance with the provisions of Article 2 (aa) of Royal Decree 889/2006, of July 21, the set of administrative, visual and technical examinations that can be carried out in a laboratory or in the place of use, which are intended to verify and confirm that an instrument in service has since its last verification the metrological characteristics which apply to it, in particular as regards the maximum permissible errors, as well as function according to their design and conform to their specific rules and, where applicable, the approved design or model.

Article 13. Bound subjects and requests.

The holders of the instruments referred to in Article 1 of this order shall be required to apply for the two years of putting into service, or, where appropriate, since the last verification carried out, the periodic verification of the same to the competent public administration or to the verification body, the use of which is prohibited in the event that this stage of metrological control is not exceeded.

The application for verification shall be submitted by completing the bulletin set out in Annex II.

Once the application for periodic verification of a temperature thermometer or recorder has been submitted, the competent public authority or the authorised metrological verification body shall have a the maximum period of 30 days for verification.

Article 14. Testing and execution.

The instrument must pass an administrative examination, consisting of the complete identification of the instrument and the verification that it meets the requirements required to be legally in service. It shall be carried out on the basis of the information provided by the applicant in the identification bulletin set out in Annex II. It shall be determined in particular that the instrument has the declaration of conformity or, where appropriate, the approval of the model, and the corresponding markings in accordance with the provisions of Royal Decree 889/2006 of 21 July 2006.

The instruments referred to in Article 1 of this order shall be subject to the tests set out in Annex III thereto.

Article 15. Maximum errors allowed.

The maximum errors allowed in the periodic verification are those indicated in Annex III.

Article 16. Compliance.

Exceeding the periodic verification phase, the conformity of the thermometer or the temperature recorder shall be recorded to perform its function, by the adhesion of a label in a visible place of the verified instrument, which shall meet the characteristics and requirements set out in Annex I to Royal Decree 889/2006 of 21 July 2006, specifying the instrument concerned. The corresponding certificate of verification shall also be issued.

Article 17. Not exceeding verification.

When an instrument referred to in Article 1 of this order does not exceed the periodic verification, it shall be put out of service until the deficiency that has prevented the improvement is remedied. This circumstance shall be indicated by means of a disable label for use, the characteristics of which are set out in Annex I to Royal Decree 889/2006 of 21 July 2006, specifying the instrument concerned. In the event that such a deficiency is not remedied, appropriate measures shall be taken to ensure that it is definitively withdrawn from the service.

Single transient arrangement. Instruments in service.

Temperature thermometers and loggers that are in service at the entry into force of this order may continue to be used while they exceed the periodic verification in the terms established therein.

The temperature recorders that would have obtained approval of their models according to the Order of the Ministry of Public Works of 2 September 1996 regulating the metrological control of the State on the registrars of Temperature in the transport of ultra-frozen products for human consumption may continue to be placed on the market until the end of the period of validity of its model approvals. Prior to placing on the market, a complementary label or plate shall be placed on the instrument indicating the accuracy class of the instrument according to the standard UNE-EN 12830.

Single repeal provision. Regulatory repeal.

The Order of the Ministry of Public Works of 2 September 1996 is hereby repealed and regulates the State's metrological control over temperature recorders in the transport of ultra-frozen products for consumption. human.

Final disposition first. Competence title.

This order is dictated by the provisions of article 149.1.12. of the Constitution, which attributes to the State, as exclusive competence, the legislation of weights and measures.

Final disposition second. General rules of application to administrative procedures.

In this order and Royal Decree 889/2006 of 21 July 2006, the administrative procedures to which the actions regulated in this order will take place will be governed by the provisions of Law 30/1992, November 26, Legal Regime of Public Administrations and the Common Administrative Procedure, and in the specific legislation of the competent public administrations.

Final disposition third. Authorization to modify the technical content of the order.

The Secretary-General of Industry is hereby authorized to introduce in the Annexes to this order, by means of a resolution and a report of the High Council of Metrology, any amendments of a technical nature to the keep their content adapted to the technical innovations that occur.

Final disposition fourth. Entry into force.

This order will take effect the day following your publication in the Official State Gazette.

Madrid, 22 November 2006. -Minister for Industry, Tourism and Trade, Joan Clos i Matheu.

ANNEX I

Testing for compliance assessment

Module B:

The conformity assessment to be carried out in application of Module B is that described in Annex III to Royal Decree 889/2006 of 21 July 2006.

The tests to be performed and successfully completed by the instrument are those provided for in the following table, which refers to several paragraphs of the UNE-EN 12830 and UNE-EN 13485 standards:

Mechanical Vibrations

provided protection grades

Electromagnetic Compatibility (EMC) (4)

Trials	Static Installation	Transport	Une-EN 12830	Appliances from the UNE-EN 13485
Determination of the error on the temperature measure	+	+	5.3	5.3
+	+		+		+	+	Centro_table_body " >5.4
the error in the time (1)	+	+	5.5	-
Variation in power voltage (2)	+	+	5.6.2	5.5.2
	5.6.9	+	+	+	+ Centro_table_body " >5.5.8
temperature influence	+	+	5.6.3	5.5.3
testing on storage and transport conditions	+	+	5.6.4	5.5.4
Resistance to shocks (3)		+	5.6.5	5.5.5
	+	5.5.6	5.5.6
	5.5.6
+	+	+	5.6.7	5.5.7
+	+	-	-

(1) Only in temperature loggers.

(2) If applicable.

(3) In thermometers, only for fixed thermometers.

(4) The logger or thermometer must conform to the requirements of UNE-EN 61000-6-3 and UNE-EN 61000-6-1 or any other specific rule when applicable.

+ Apply the corresponding test.

The model examination must specify the characteristics of all the possible elements that the entire measurement chain contemplates.

The maximum errors allowed in the tests inherent in the model examination shall be those indicated in paragraph 6.2 of the Spanish standard UNE-EN 13485, for thermometers, and paragraphs 6.2 and 4.9.2.4 of the Spanish standard UNE-EN 12830, for temperature loggers.

Any temperature recorder or thermometer manufactured in accordance with an evaluated model, as well as its sensors, must bear the indications provided for in paragraph 8 of the Spanish standards UNE-EN 12830 and UNE-EN 13485, for temperature loggers and thermometers, respectively.

Module F:

The conformity assessment for Module F is that described in Annex III of RD 889/2006 of 21 July 2006.

The tests to be performed and successfully completed by the instrument are those indicated in paragraph 5.3 of the Spanish standard UNE-EN 13485, for thermometers, and in paragraphs 5.3 and 5.5 of the Spanish standard UNE-EN 12830, for temperature loggers, as well as the correct marking and sealing defined in their corresponding model examinations.

The maximum errors allowed in the tests shall be those set out in paragraph 6.2 of the Spanish standard UNE-EN 13485, for thermometers, and paragraphs 6.2 and 4.9.2.4 of the Spanish standard UNE-EN 12830, for temperature recorders. The correct operation of all the data display, printing and unloading devices associated with the logger and which appear in the model examination shall be checked.

Once the tests for this module have been carried out with satisfactory results, in the case of instruments requiring subsequent installation for which a seal must be lifted and restituted modification of the initial connection, the correct operation of the instruments shall be checked once they have been installed, and shall be sealed.

If the assembly, in addition, involves making changes to the connection or installation of new conductors, contemplated in the model examination between the temperature sensors and the reading equipment with respect to the set that has been tested, the tests for the verification after repair or modification described in Chapter III shall be carried out.

Module G:

The conformity assessment to be carried out in application of Module G will be performed under the same criteria determined for Module B.

ANNEX II

Verification Request

ANNEX III

Applicable technical rules

The essential, metrological and technical requirements to be met by the instruments are those specified in paragraph 4 of the UNE-EN 12830 and UNE-EN 13485 standards, for temperature recorders and thermometers, respectively.

The maximum errors allowed in the periodic verification or after repair or modification shall be those indicated in paragraphs 5.6 and 6.4 of the Spanish standard UNE-EN 13486, for temperature recorders, and paragraph 5.6, for thermometers.

The tests corresponding to the periodic verification are those referred to in paragraph 5 of the Spanish standard UNE-EN 13486, for thermometers, and those indicated in paragraphs 5 and 6 of that standard, for registrars of temperature.