Bureau for Chemical Substance

Good Laboratory Practice is a quality system used for organisational process and conditions of planning, conducting and monitoring of non-clinical studies of substances and their mixtures   regarding safety to human health and the environment, and documenting, archiving and presenting results of such studies.  

The principles of good laboratory practice are applied in non-clinical studies regarding safety of medicinal products, veterinary drugs, plant protection products, cosmetic products, biocidal products, food additives, feed additives, detergents, and chemicals used in industry, services and in households. The studies in which the principles of good laboratory practice are used include studies in laboratories, studies in greenhouses, and field studies.

The principles of good laboratory practice have been drafted for the purpose of ensuring high quality and reliability of data to avoid their duplication in various countries. The system is mainly introduced in member states of the Organisation for Economic Co-operation and Development (OECD), however also non-OECD states introduce GLP therefore it has gained a global reach. Equally important is the aim of decreasing the number of laboratory animals sacrificed for the purpose of the studies. On the one hand, it leads to measurable savings, and strengthens the protection of laboratory animals on the other. Decision C(81)30/Final of the OECD Council concerning the mutual acceptance of data in the assessment of chemicals (amended by the Decision of the Council C(97)186/Final) has introduced common application of the principles of good laboratory practice among OECD member states. This Decision stipulates that the data generated during testing of the chemicals in one of the OECD member states, carried out with the application of methods specified in Annex I to this Decision and according to the principles of good laboratory practice specified in Annex II to this Decision, should be accepted in other OECD member states for the assessment of tested products and for other purposes related to the protection of human health and the environment.

National Good Laboratory Practice Compliance Programme

The President of the Bureau for Chemical Substances communicates about publishing update of the National Good Laboratory Practice Compliance Monitoring Programme in the Public Information Bulletin of the Bureau for Chemical Substances. The National Good Laboratory Practice Compliance Monitoring Programme constitutes the annex to this communiqué.

The publishing of the National Good Laboratory Practice Compliance Monitoring Programme by the President of the Bureau for Chemical Substances is required by the Article 16 (5) of the Act of 25 February 2011 on the chemical substances and their mixtures (Journal of Laws of the Republic of Poland [Dziennik Ustaw] of 2022, item 1816) in accordance with the requirements of OECD guidelines and the EU provisions on the Good Laboratory Practice compliance monitoring.

The list of certified test facilities

The list of certified test facilities, for which the President of the Bureau for Chemical Substances has confirmed in a decision, their compliance with the principles of good laboratory practice.

The list also contains information on the facilities that have been deleted from the list of certified test facilities.

 

The EU legal acts

• Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version - OJ L 50, 20.02.2004)
• Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (Codified version -  OJ L 50, 20.02.2004) 

Polish legal acts

• Act of 25 February 2011 on the chemical substances and their mixtures (Journal of Laws 2022, item 1816);
• Regulation of the Minister of Health of 3 August 2021 on Good Laboratory Practice and Performance of Studies in Compliance with the Principles of Good Laboratory Practice (Journal of Laws 2021, item 1422);
• Regulation of the Minister of Health of 19 June 2012 on the amount and method of payment of the fees by test facilities for the inspection and verification of the compliance with the principles of good laboratory practice (Journal of Laws 2012, item 723).

The OECD guidelines and documents

The OECD guidelines and documents concerning good laboratory practice are available on the OECD website: OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring.

Test methods

Accurate monitoring of the compliance by certified test facilities carrying out the studies in accordance with the principles of good laboratory practice harmonised in all countries is a necessary condition for the mutual acceptance of data obtained in such test facilities as well as reliable and harmonised test methods.

A set of harmonised test methods is presented in Annex I, subject to several amendments, to the Decision C(81)30/Final of the OECD Council concerning the mutual acceptance of data in the assessment of chemicals. Test methods currently approved by the OECD Council are posted on the OECD website: Test Guidelines for the Chemicals.

In the European Union the OECD-adopted test methods are implemented through Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Text of Regulation (EC) No 440/2008 including regulations adapting this regulation to technical progress is available on the REACH and CLP national helpdesk website.

Due to the scientific development and amendments in regulations, the test guidelines are updated and replaced by new versions. The OECD website: Test Guidelines for the Chemicals contains draft documents for public comments. It also contains information on currently updated test methods or newly developed test methods. The OECD also publishes invitations to submit comments on the updated or newly developed test methods. Entities interested in submitting such comments include enterprises, sectoral organisations, representatives of test facilities or certified test facilities. The comments shall be submitted via the National Coordinators of the Test Guidelines Programme.

Request to become a new test facility and fees

Test facilities performing studies in compliance with the principles of good laboratory practice within the territory of the Republic of Poland may participate in the Programme, irrespective of the form of their ownership.

Pursuant to Article 16(2) of the Act on the chemical substances and their mixtures, the inspection and verification whether an entity which tests substances and their chemical mixtures complies with the principles of good laboratory practice in order to grant it a Good Laboratory Practice certificate and register it in the register of the certified test facilities shall be conducted at the request of this facility.   

Pursuant to Article 17(1)(1) of the Act on the chemical substances and their mixtures, a test facility which submits the request to deliver the inspection and verification of its compliance with the principles of good laboratory practice in order to grant it a Good Laboratory Practice certificate and register it in the register of the certified test facilities has to pay a one-time fee. The certified test facilities are obliged to pay a fixed annual fee, referred to in Article 17(1)(2)  of the Act on the chemical substances and their mixtures.

The one-time fee and the annual fee referred to in the provisions of the Regulation of the Minister of Health on the amount and method of payment of the fees by test facilities for the inspection and verification of the compliance with the principles of good laboratory practice is 6000 PLN.

The one-time fee shall be paid at the time of submission of the request for granting the certificate and the entry in the register of the certified test facilities. Where the certificate and the entry in the register of the certified test facilities are granted, the one-time fee shall become the annual fee for the year in which the test facility has received the certificate. The fees do not constitute the revenue of the Bureau and are transferred to the state budget.

Pursuant to Article 17(3a) of the Act on the chemical substances and their mixtures, where the fixed annual fee has not been paid, the President of the Bureau for Chemical Substance in a decision shall revoke the granted certificate and delete the certified test facility from the register of certified test facilities.

The fees shall be paid using the following bank account number of the Bureau for Chemical Substances:

Narodowy Bank Polski

Oddział Okręgowy w Łodzi

32 1010 1371 0015 3122 3100 0000