Key Benefits:
Publics concerned: manufacturers of chemical ethytests and drivers of terrestrial motor vehicles.
Purpose: Statement of the reliability and safety requirements of chemical ethylotests for pre-road use.
Entry into force: the text comes into force on the day after its publication.
Notice: This Order sets out the safety and reliability requirements of chemical ethylotests for pre-road use. These requirements are fixed independently of any mandatory reference to a standard in order not to impede the free movement of products within the European Union. In particular, they prevent an incorrect result from the decision to drive under the empire of an alcoholic state with a concentration of alcohol in the expired air greater than the limit values set by the road code.
References: This decree is available on the website Légifrance (http://www.legifrance.gouv.fr).
The Prime Minister,
On the report of the Minister of Interior,
Having regard to Regulation (EC) No 764/2008 of the Parliament and Council of 9 July 2008 establishing procedures for the application of certain national technical rules to products legally marketed in another Member State and repealing Decision No. 3052/95/EC;
In light of the amended Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 providing for an information procedure in the field of technical standards and regulations and rules relating to the services of society and information, together with notification No. 2014/416/F of 28 August 2014 to the European Commission;
Vu le Consumer codeincluding article L. 221-3;
Vu le Customs Codeincluding article 38;
Vu le Criminal codearticles 131-41, 132-11, 132-15 and R. 610-1;
Vu le road codeincluding articles L. 234-3, L. 234-7, L. 234-14, R. 233-1, R. 234-1, R. 234-2 and R. 234-7;
Vu le Public Health Codeincluding article L. 3341-4;
Vu la Act No. 2011-525 of 17 May 2011 simplifying and improving the quality of law, including article 16;
Vu le Decree No. 2009-697 of 16 June 2009 on Standardization;
Considering the opinion of the permanent interdepartmental road safety group of 17 December 2014;
The State Council (section of public works) heard,
Decrete:
This Order applies to chemical ethylotests intended for pre-road use. For the purposes of this decree, chemical ethylotests intended for pre-road use are the screening devices for single-use alcoholic impregnation intended to estimate the concentration of alcohol in the air expired by a driver, in the light of the limit values fixed under the limits of I of section R. 234-1 of the road code.
It is prohibited to manufacture, import, hold for sale or distribution on a free basis, to sell, sell, distribute on a free basis or to make available chemical ethylotests intended for use prior to road driving if they do not meet the conditions set by this decree.
I. - Chemical ethylotests for pre-road use meet the reliability and safety requirements listed in the appendix to this decree in order to ensure the safety of persons, including by preventing the consequences of an erroneous result resulting in the decision to drive under the empire of an alcoholic state with a concentration of alcohol in the expired air greater than the limit values set out in I of section R. 234-1 of the road code.
II. - The packagings of chemical ethylotests for pre-road use are equipped with markings in visible, legible and indelible form:
1° Identification of the manufacturer and the manager of the first bet on the market;
2° The deadline for use of ethyotest in the order of the month and year, preceded by a sentence such as "to be used before:";
3° The minimum and maximum values of ethylotest temperatures;
4° The concentration of ethanol in the expired air expressed in mg/l of expired air and g/l of blood for which ethylotest was manufactured, with reference to one of the limit values attached to the I of section R. 234-1 of the road code ;
5° An indication in the form of text, drawing or pictogram indicating that chemical ethyotest is intended for use prior to road driving.
III. - The instructions for use delivered with each chemical ethylotest intended for pre-drive use are written in terms that are readily understandable by the consumer and contain at least the following information:
1° The concentration of ethanol in the expired air expressed in mg/l of expired air and in g/l of blood for which the chemical ethylotest for pre-road use was manufactured, with reference to one of the limit values attached to the I of section R. 234-1 of the road code ;
2° Specific requirements for storage and use conditions;
3° The method of reading the result;
4° A warning, in the form of text or pictogram, calling attention to not leaving ethylotest within the reach of children.
The following products are deemed to satisfy the provisions of section 3:
1° Compliance with the standards of which references are published in the Official Journal of the French Republic.
The person responsible for the first placing on the market of these products shall be at the disposal of the inspection officers the documents containing a detailed description of the product and the technical repository used to verify the conformity of the product to the safety requirements, the results of the tests carried out, a description of the means by which the manufacturer ensures the conformity of its production to the model, as well as the address of the production or storage places for placing on the market;
2° Either in accordance with a model that receives a certificate of conformity with the requirements of reliability and security of this decree, issued following a type examination by a French body or another Member State of the European Union or another State Party to the agreement on the European Economic Area or Turkey, accredited for the testing of the products referred to in Article 1 by the French Committee for Multilateral Accreditation (COFRAC) or
The person responsible for the first placing on the market of these products shall be at the disposal of the inspection officers a file comprising the certificate of compliance with the requirements of reliability and safety, a detailed description of the model and the means by which the manufacturer ensures compliance with its production to the model that was the subject of the type examination and the address of the production or storage sites for the marketing.
The documents referred to in this article shall be retained three years from the date of the last sale by the person responsible for the first marketing of the corresponding product.
The provisions of this decree do not constitute an obstacle to the free movement of chemical ethylotests intended for pre-use road driving legally manufactured or marketed in another Member State of the European Union, or in another State Party to the Agreement on the European Economic Area, or in Turkey, ensuring a level of reliability and security equivalent to that guaranteed by this decree.
Is punished by the fine provided for fifth class offences:
1° To manufacture, import, hold for sale or distribution on a free basis, to sell, sell, distribute on a free basis or to make available the products mentioned in Article 1 that do not meet the requirements of Article 3 II and III or the requirement of reliability provided for in Article I;
2° Not being able to present the documents referred to in Article 4.
The recurrence of the contraventions provided for in this section is repressed in accordance with the sections 132-11 and 132-15 Criminal code.
The provisions of this Order are applicable to products manufactured from the date of entry into force. Products manufactured prior to the effective date of this Order and that meet the requirements set out in the NF X20-702 standard published in the Official Journal on June 6, 2007 or equivalent technical specifications may be held for sale, distributed free of charge, made for sale, sold, distributed free of charge and made available until their use deadline.
The Minister of Justice, the Minister of Social Affairs, Health and Women's Rights, the Minister of the Interior and the Minister of Economy, Industry and Digital Affairs are responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.
Annex
FIABILITY AND SECURITY
1. General security requirement
Users of chemical ethyotes for pre-road use and third parties must be protected, under normal conditions of use or under other reasonably foreseeable conditions, from the risks to their health and safety.
2. Reliability requirements
2.1. Aptitude to use
The absence of a defect in the use of chemical ethylotests for pre-drive use (creve ball, broken tube, etc.) must be at least 98% of a 50 ethylotest lot of the same model tested.
The chemical ethylotest for pre-carriage use must be used at temperatures between 10 °C and 40 °C.
2.2. Reliability of screening results
Tests to verify the reliability of the test result by chemical ethylotests for pre-drive use shall be conducted at C1 and C2 concentrations as defined:
- for a value of C greater than or equal to 0.16 mg alcohol per litre of expired air:
C1 = (C - 0.13) × (V - 0.25)/V
C2 = C × (V - 0.25)/V
- for a value of C between 0.15 and 0.10 mg of alcohol per litre of expired air:
C1 = (C - 0.08) × (V - 0.25)/V
C2 = C × (V - 0.25)/V
where:
- C is the concentration of ethanol in the permitted maximum expired air, with reference to one of the limit values attached to I of section R. 234-1 of the road code ;
- V is the volume of blowing liter recommended by the manufacturer (0.25 represents an average dead volume of 250 ml free of alcohol during the expiration), which allows its identification by the user by the presence either of a limiting pocket or a device indicating that the volume of air required for analysis has been achieved.
In order to guarantee the user the reliability of the result obtained during a control breath, 100% of the tests performed at C2 must be positive and 95% of the tests performed at C1 must be negative.
The test validity criteria for C1 are as follows:
(a) At least 48 negative results when controlling a lot of 50 ethylotests of an identical model;
(b) In the event of obtaining 45 to 47 negative results when controlling a first batch of 50 ethylotests of an identical model, a new batch of 50 ethylotests of an identical model is tested. For both batches, 95 negative tests must be obtained to validate this criterion.
The tests are performed in particular at the minimum and maximum values of the temperature of use mentioned on the packaging of the product by the manufacturer.
Done on June 29, 2015.
Manuel Valls
By the Prime Minister:
The Minister of the Interior,
Bernard Cazeneuve
The Seal Guard, Minister of Justice,
Christiane Taubira
Minister of Social Affairs, Health and Women ' s Rights,
Marisol Touraine
Minister of Economy, Industry and Digital,
Emmanuel Macron
