Training on standardisation Support to the Modernisation of the Mongolia’s Standardisation System (SMMSS) Training on standardisation Unit 3 Essential requirements Harmonised standards Presumption of conformity *

Essential requirements in EU legislation Essential requirements define the results to be attained, or the hazards to be dealt with, but do not specify the technical solutions for doing so. These requirements deal with the protection of health and safety of users (usually consumers and workers) but may also cover other fundamental requirements (for example protection of property, scarce resources or the environment). Essential requirements must be applied as a function of the hazard inherent to a given product. Therefore, manufacturers have to carry out risk analysis and determine the essential requirement applicable to the product.

Examples of essential requirements General safety requirement: Toys, including the chemicals they contain, shall not jeopardise the safety or health of users or third parties when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children. The ability of the users and, where appropriate, their supervisors shall be taken into account, in particular, in the case of toys which are intended for use by children under 36 months or by other specified age groups. Labels affixed in accordance with Article 11(2) and instructions for use which accompany toys shall draw the attention of users or their super visors to the inherent hazards and risks of harm involved in using the toys, and to the ways of avoiding such hazards and risks. (Directive 2009/48/EC on the safety of toys)

Harmonised standards Definitions: standard technical specification, adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory European standard standards adopted by CEN/CENELEC/ETSI (recognized by EU, Regulation (EU) No 1025/2012) Harmonised standard European standards adopted, upon a request made by the Commission for the application of Union harmonisation legislation

European and national standards All European standards must be transposed at national level by the national standardisation bodies. This transposition means that the European standards in question must be made available as national standards in an identical way, and that all conflicting national standards must be withdrawn in a given period.

EU standardisation requests to the ESOs The Commission formally requests the European standardisation organisations to present harmonised standards by issuing a standardisation request (mandate). Prior to this the Commission consults the Member States. Obtaining standards based on consensus implies a wide consultation of sectoral authorities at national level. Thus, the mandate provides a strong indication of the expectations of public authorities

EU standardisation requests to the ESOs The European standardisation organisations will formally take a position on a mandate from the Commission in conformity with their internal rules. Acceptance of the mandate and the subsequent standardisation work initiate the standstill period for national standardisation bodies as provided for in the case of harmonised standards, in Regulation (EU) No 1025/2012.

Elaboration of harmonised standards The elaboration and adoption of harmonised standards is based on Regulation (EU) No 1025/2012 and on the General Guidelines for cooperation between the European standardisation organisations and the Commission and EFTA from 28 March 2003. There are a number of requirements, principles and commitments concerning standardisation, such as the participation of all interested parties (for example manufacturers, including SMEs, consumer associations, environmental stakeholders and trade unions), the role of public authorities, the quality of standards and a uniform transposition of European standards throughout the Union by national standardisation bodies. The technical contents of such harmonised standards are under the entire responsibility of the European standardisation organisations

Elaboration of harmonised standards The European standardisation organisations decide on the mandated work programme for harmonised standards in line with the relevant mandate. They may also identify existing standards that they judge, after examination and possible revision, to meet the terms of the mandate, or modify existing standards in order to meet those terms. In the same way, they may identify international or national standards and adopt them as European standards, and present them to the Commission as harmonised standards. A harmonised standard must match the relevant essential or other legal requirements of the relevant piece of legislation in line with the relevant mandate.

Elaboration of harmonised standards

Presumption of conformity Harmonised standards provide a presumption of conformity with the essential requirements they aim to cover, if their references have been published in the Official Journal of the European Union (OJEU). References of harmonised standards are published as Commission Communications in the C series of the OJEU.

Cosmetic products

Exampel of reference to harmonised EN

Exampel of reference to harmonised EN

Cosmetic products

Where to find the harmonised standards Web sites The European Commission's Directorate-General for Enterprise and Industry, Harmonised standards, http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/index_en.htm New Approach Standardisation in the Internal Market, http://www.newapproach.org/ Standards sales points, http://www.newapproach.org/SalesPoints/SalesPoints.asp

Conformity by the use of other means The recourse to harmonised standards cited in the OJEU and which give a presumption of conformity remains voluntary. The manufacturer can choose whether or not to refer to such harmonised standards. However, if the manufacturer chooses not to follow a harmonised standard, he has the obligation to demonstrate that his products are in conformity with essential requirements by the use of other means of his own choice (for example by means of any existing technical specifications including all other available standards).

Thank you for your kind attention Support to the Modernisation of the Mongolian Standardisation System (SMMSS) Thank you for your kind attention Folke Hermansson Snickars folke@ambiprospect.com This project is supported by the European Union