Good Laboratory Practice (GLP)
The principles of Good Laboratory Practice (GLP) are applied in the performance of tests to obtain data on the properties and hazards for people, animals and the environment of any chemical substance. The purpose of these tests is to submit the substances studied to the regulatory authorities responsible for their official registration as a preliminary step to marketing.
As non-clinical health and environmental safety tests, they have regulatory purposes.
Adopted by the OECD in 1981, GLP provides recommendations for managing these tests and provides a quality system for the organisational processes and conditions under which the tests are planned, conducted, controlled, recorded, archived and reported, to guarantee the quality and validity of the data obtained.
The tests covered by GLP fall into four categories based on their purpose:
- Physico-chemical properties.
- Toxicological studies, designed to assess effects on human health.
- Ecotoxicology studies on aquatic or terrestrial organisms: designed to assess effects on the environment.
- Ecological studies on behaviour in water, soil and air, or bioaccumulation: designed to assess environmental destination and performance.
National GLP Compliance Programmes are in place to ensure compliance with GLP by the bodies that conduct the tests. Furthermore, the signing of Mutual Recognition Agreements (MRA) on data ensures that the results of these tests are recognised by other countries in the EU and OECD.
ENAC is the organisation designated by the competent Spanish gGovernment agencies as the control body for assessing and certifying GLP compliance in studies conducted with plant protection products, feed additives and industrial chemicals, thereby ensuring compliance with the European directives regulating this activity.
To complete its task, ENAC has a specific GLP, area and any organisation interested in obtaining the GLP certificate can request an inspection and the necessary documentation from this website.
Feed additives and plant protection products
Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC establishes that only plant protection products with approved active substances may be marketed in the EU and indicates in several of its articles that the data must be obtained from studies conducted in accordance with Good Laboratory Practice (GLP).
The approval procedure for an active substance is complex and requires the manufacturer (or importer) to submit a wealth of information on aspects such as physicochemical properties, analytical methods, toxicological and metabolic studies, levels of residues in treated products, behaviour in the environment, etc., as a means of protecting consumer health.
To obtain this information, numerous studies must be conducted under GLP, covering both experimental activities in the laboratory and “in the field” (or on plots of crops, greenhouses, ponds, etc.).
The registration of formulations in any Member State also requires GLP studies, mainly on residues, for the purpose of authorising their marketing and setting the legally permitted maximum residue limits (MRL).
ENAC was designated in 1995 by the Ministry of Agriculture, Food and Environment as the control authority for the GLP compliance Programme for plant protection products, which was updated in November 2014 to include feed additives after ENAC was designated as the control authority for these products by the same Ministry.
Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives is applicable to additives for animal feed. Its Annex II requires studies (including those conducted and published previously or from peer reviews) to be conducted and documented according to suitable quality standards, such as Good Laboratory Practice according to Directive 2004/10/CE.
The "Accredited Bodies" section contains details of all organisations with GLP certification for Plant Protection Products and Feed Additives that conduct these studies in accordance with GLP.
Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) establishes the obligation of manufacturers to register substances manufactured or imported in the European Union to ensure responsible management of the hazards for human health and the environment of these substances, reforming their marketing conditions by introducing a registration system associated with the assessment of certain products, the authorisation of those of most concern and their restriction in certain cases. Biocides are regulated in Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market.
In November 2007, ENAC was designated by the Ministry of the Presidency, at the proposal of the ministries of Health and Consumption, Industry, Trade and Tourism and the Environment, as the assessment and certification body for Good Laboratory Practice (GLP) for the GLP compliance programme for industrial chemicals, which includes biocides and substances regulated by the European regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation.
The "Accredited Bodies" section contains details of all organisations with GLP certification for Industrial Chemicals that conduct these studies.
All ENAC documentation relative to accreditation criteria and procedures for tests covered by GLP is available in the Documents section.