ENAC passes the rigorous assessment process conducted by the OECD audit team without any deviations

ENAC, as the government-appointed body for assessing and certifying Good Laboratory Practices (GLP), during the month of May, received the Organization for Economic Cooperation and Development (OECD) audit team in order to assess the Programs for monitoring compliance with GLP principles in non-clinical trials for plant protection products, feed additives, industrial chemicals, biocides and food additives.

This assessment is essential for maintaining full compliance with the OECD's 'Mutual Acceptance of Data' (MAD) agreement, which facilitates reports issued by ENAC-accredited laboratories being accepted in other countries that are signatories to the agreement. For five days, OECD representatives thoroughly reviewed the setting-up of ENAC-managed GLP programs, both at ENAC offices and at selected testing facilities. The agenda included technical sessions with regulatory authorities such as the Ministry of Health, the Ministry of Agriculture, Fisheries and Food (MAPA), and the Spanish Agency for Medicines and Health Products (AEMPS), as well as direct observation of a testing body inspection.

The result was very satisfactory, with no deviations detected in our system, highlighting the solid rigor of the assessment process followed by ENAC. Therefore, among the report's notable aspects, it was noted that “each component of the GLP assessment program—including administrative management, confidentiality agreements, staff training, and inspection and appeals procedures—meets the requirements established by the OECD.”

The assessment team’s inspection confirmed the inspector’s technical knowledge, the assessment report highlighted their “solid knowledge and understanding of GLP principles.” Additionally, the report's conclusions emphasized “their preparation and organizational ability to conduct inspections in a structured and professional manner.”

Finally, the assessment team concluded that "Spanish Good Laboratory Practice (GLP) compliance assessment programs managed by ENAC - in the areas of plant protection products, industrial chemicals and biocides, feed additives, food additives, enzymes and flavourings, novel foods, and technological auxiliaries - fully comply with the requirements set out in OECD Series on Principles of GLP Documents No. 2, 3, and 9." For all these reasons, it indicated that "the compliance decisions adopted by ENAC are equivalent to those of other international assessment programmes" and that "ENAC, together with the practices and procedures it applies in inspecting GLP studies in its area of competence in Spain, complies with the requirements set out in the OECD Guidance Documents for GLP Assessment Authorities".

Finally, it highlights 'ENAC’s good practices that could be adopted by other assessment programs,' conducting periodic assessment of chief inspectors and technicians in order to inspect and ensure their competence in carrying out inspections.

Representation before the OECD and the EU

ENAC represents Spain in Good Laboratory Practice programs in working groups of the Organisation for Economic Co-operation and Development (OECD) and the European Union (EU).

The OECD has established a “Mutual Acceptance of Data” (MAD) agreement, which aims for data obtained from non-clinical health and environmental safety studies required by regulations to register or authorize products to be accepted in any MAD signatory country, in order to avoid studies or tests being repeated in destination countries, thereby eliminating technical barriers to trade and reducing the number of tests, costs, and time.

Full adherence to this Agreement following the assessments conducted by the OECD on ENAC enables the data generated by ENAC-inspected testing bodies and declared compliant with GLP to be accepted by the signatory countries.

ENAC and GLP Certification: Safety for the Market and the Consumer

Many of the chemical and biological products we use in our daily lives, such as pesticides, biocides, food additives, or industrial substances, can affect both human health and the environment. For this reason, before being authorized and marketed, they must go through a registration process where their safety is demonstrated through rigorous controls and assessments. In this context, the competent authorities review and validate these assessments, which have to be conducted in compliance with requirements established in international standards. This is where Good Laboratory Practices (GLP) come into play, and where assessments and certifications ensuring the reliability of the results become relevant.

GLP is a set of international principles and standards that establish how non-clinical laboratory tests (that is, those not conducted on humans) should be planned, conducted, recorded, and reported to ensure the generated data’s quality, integrity, and reliability and to ensure the validity and reproducibility of the results obtained in scientific tests and studies.

In this regard, setting up good laboratory practices (GLP) offers numerous significant benefits for research laboratories involved in developing new products intended for registration and commercialization. The principles establish, among other things, that the data generated in these studies is accurate and that they maintain detailed records of the entire study, since the ultimate goal of these studies is to ensure the safety of products before they go on the market and, therefore, to prevent harmful effects to human and animal health or adverse impacts on the environment.

GLPs also promote harmonizing regulations between different countries, aiding international cooperation and the mutual recognition of data obtained from conducting studies, always prior to registering new products in the different countries.

Therefore, laboratories and bodies with GLP certification do not carry out routine tests; rather, their work is geared toward research. In short, GLP essentially constitutes a way of working that helps prevent malpractice when performing tests, and the inspection system of bodies operating according to GLP brings clear benefits to society.

The Principles of Good Laboratory Practice (GLP), adopted by the Organisation for Economic Co-operation and Development (OECD) in 1981, explicitly establish the testing areas that must be applied to products subject to authorization, as defined in Decision C(89)87. The defined areas are: physicochemical testing, toxicity studies, mutagenicity testing, ecotoxicological studies on aquatic and terrestrial organisms, studies of behaviour in water, soil, and air; bioaccumulation, residues, studies of effects in mesocosms and natural ecosystems, clinical biochemistry and analytical chemistry, and other studies.

Currently, ENAC has nearly 40 certificates of compliance with Good Laboratory Practices (GLP): 27 in plant protection products, including two of them feed additives, 8 in biocides, and 4 in industrial chemicals, including one of them food additives.

Most of it corresponds to plant protection products, a field where 17 bodies conduct field studies, which in many cases are multicentred, meaning they are carried out in a coordinated manner across several countries.

( Good Laboratory Practices.                                   Evolution of the number of Accreditations)

Accreditation by area: -

plant protection products 25

biocides 6

Chemical industry substances 3

Food additives 2

 

In addition to these bodies, there are 10 laboratories that carry out supplementary analyses, usually with samples collected during these field tests. An example could be the analysis of a new pesticide applied to a tomato crop. These studies provide essential information for authorities to set the maximum pesticide residue limits allowed by law when approving the product.

Also, many of these bodies conduct studies on these product’s behaviour in the soil to understand how they are distributed in the environment and their rate of degradation.

Physicochemical tests are also key to understanding the product’s characteristics before it goes on sale, such as its content, density, pH, surface tension, flash point, storage stability, etc.

The importance of ecotoxicological studies lies in the fact that they determine the toxic effects of the test product on aquatic and terrestrial organisms, as well as non-target organisms, such as bees and bumblebees, which are very important for future crops.

To a lesser extent, this type of body/laboratory conducts toxicity and mutagenicity studies, which are very important before carrying out the required clinical trials prior to authorization.

In short, maintaining the body inspection system that carries out these studies in compliance with GLP principles, conducted by ENAC, is very important, not only for the assessment bodies but also to provide confidence in the studies’ quality and reliability, with these benefits ultimately impacting public health, environmental protection, and consumer trust.