The New Legal Framework

The actual legislative framework was adopted in 2008 and was named "New Legal Framework". It is a package of measures aimed at improving market surveillance and increasing the quality of conformity assessments. It also clarifies the use of the CE mark and creates a series of measures to be used in the product legislation.

The legal acts composing the New Legal Framework (NLF) package were published in the OJEU L 218/82 on 13 August 2008. The NLF package is the modernization of the New Approach for marketing products to strengthen the application of the internal market legislation.

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The Blue Guide is intended to contribute to a better understanding of EU product legislation and to its more uniform and coherent application across different sectors and throughout the single market. It is addressed to the Member States and to those who need to be informed of the provisions designed to ensure the free circulation of products as well as a high level of protection throughout the European Union. Its update has been launched at the beginning of 2020.

As for the instructions for use as such general harmonised standards do not exist up to now. Commonly used standards for products instructions are:

  •  IEC 82079-1 Preparation of instructions for use
  •  ISO/IEC Guide 37:2012 – Instructions for use of products by consumers

ISO/IEC Guide 37:2012 does not provide information covering each case. It offers guidance to the interested parties in the form of general principles and detailed recommendations on the design and the formulation of the instructions necessary or helpful to the user of consumer products. 

The legal acts composing the New Legal Framework (NLF) package were published in the OJEU L 218/82 on 13 August 2008. The NLF package is the modernization of the New Approach for marketing products to strengthen the application of the internal market legislation.

On 26 February 2014 an “Alignment Package” consisting of eight directives was published in the OJEU on 29 March 2014.

Scope

The scope is contained in Article 1 as follows.

1. The purpose of this Directive is to ensure that products placed on the market are safe.

2. This Directive shall apply to all the products defined in Article 2(a). Each of its provisions shall apply in so far as there are no specific provisions with the same objective in rules of Community law governing the safety of the products concerned.