32014L0031

WHAT IS THE AIM OF THE DIRECTIVE?

It lays down uniform, EU-wide rules on the sale and putting into service of non-automatic weighing instruments (NAWIs)¹. NAWIs are important for trade, consumers and industry as they ensure the accuracy of measurements and help the transparency and fairness of commercial transactions.

It aims to:

• establish the essential requirements that NAWIs have to satisfy;
• introduce simpler, clearer and more-consistent rules, thus ensuring traceability;
• reduce administrative burdens for manufacturers, importers and distributors;
• ensure that instruments compliant with the essential requirements can circulate freely within the EU.

Benefits should include:

• compliant and more accurate NAWIs on the EU market and increased levels of public trust in them;
• fewer non-compliant instruments and distortions of competition on the market arising from different enforcement practices;
• protection of the public from wrong measurements;
• increased room for technological innovation, by adopting a modern regulatory approach.

The directive recasts and repeals Directive 2009/23/EC.

KEY POINTS

The directive brings the NAWI legislation into line with the EU’s ‘new legislative framework’. This framework comprises 2 complementary texts:

• Regulation (EC) No 765/2008 on accreditation and market surveillance; and
• Decision No 768/2008/EC on uniform conditions for the marketing of safe products in the EU (conformity marking).

Scope

• The directive applies to all NAWIs that are new to the EU market when they are placed on that market or put into service, that is that they are:
  • new NAWIs made by a manufacturer established in the EU; or
  • NAWIs imported from a non-EU country, whether they are new or second hand.
• The directive applies to all forms of supply of NAWIs, including distance selling.
• The directive distinguishes the following categories of use of NAWIs for determination of weight for:
  • commercial transactions;
  • the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;
  • the application of laws or regulations or for an expert opinion given in court proceedings;
  • the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;
  • preparing medicines on prescription in a pharmacy and determining weight in analyses carried out in medical and pharmaceutical laboratories;
  • the purposes of direct sales to the public and the preparation of pre-packages.

Responsibilities of manufacturers, importers and distributors

Manufacturers must ensure that:

• all NAWIs on sale in the EU bear the conformity marking consisting of the European conformity (CE) marking plus the supplementary metrology (M) marking, with the last two digits of the year of its affixing and the accredited notified body² number(s), indicating that they meet all the essential requirements set out in Annex I to the directive;
• they lodge an application for EU-type examination with a single notified body of their choice in line with Annex II to the directive on conformity assessment procedures;
• they conduct a risk and conformity assessment and draw up technical documentation for the NAWI before affixing the CE + M markings (see Annex III to the directive);
• they (and if they appoint an authorised representative³) keep the technical documentation and the EU declaration of conformity (as set out in Annex IV to the directive) for 10 years after the NAWI has been placed on the market;
• they indicate on the NAWI their name, registered trade name or registered trade mark and the postal address where they can be contacted to ensure traceability;
• in the event they believe that NAWIs they have placed on the market do not conform, take corrective measures to bring them into conformity, withdraw or recall them;
• instructions and information accompanying the NAWI are written in language easily understood by its end users and that they, as well as any labelling, are clear and understandable.

Importers must ensure that:

• NAWIs they place on the market comply with the essential requirements;
• manufacturers have carried out conformity assessments correctly and inform the market-surveillance authority if they consider that the NAWIs do not comply;
• they indicate on the NAWI their name, registered trade name or registered trade mark and the postal address where they can be contacted;
• marking of NAWIs and documentation drawn up by manufacturers are available for inspection by the competent authorities.

Distributors must ensure that:

• NAWIs under their responsibility, their storage or transport conditions do not place at risk the instruments’ compliance with the essential requirements;
• NAWIs bear the necessary markings;
• in the event they believe that NAWIs they have made available on the market do not conform, take corrective measures to bring them into conformity, withdraw or recall them.

In addition, the directive:

• introduces requirements for notifying authorities and the procedures for notification;
• specifies how national authorities that monitor safety must identify and prevent the import from non-EU countries of NAWIs that endanger the health and safety of persons;
• includes rules on penalties for infringements by manufacturers, importers and distributors which may include criminal penalties in serious cases.

FROM WHEN DOES THE DIRECTIVE APPLY?

Directive 2014/31/EU revised and replaced Directive 2002/95/EC and had to be applied in the EU countries as of 20 April 2016.

BACKGROUND

For more information, see:

• Legal metrology (European Commission).

KEY TERMS

1. Non-automatic weighing instrument: a weighing instrument requiring human intervention during weighing.
2. Notified body: an independent organisation designated by an EU country to assess the conformity of certain products before they are placed on the market. It carries out tasks related to conformity-assessment procedures set out in the relevant legislation, when the intervention of an external authority is required.
3. Authorised representative: any individual or organisation established in the EU with a written mandate from a manufacturer to act on their behalf.

MAIN DOCUMENT

Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (recast) (OJ L 96, 29.3.2014, pp. 107-148)

RELATED DOCUMENTS

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, pp. 30-47)

Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, pp. 82-128)