Chemical safety and biosafety

Mutual Acceptance of Data (MAD)

 

The chemicals industry (industrial chemicals, pharmaceuticals, pesticides, biocides, food and feed additives and cosmetics) is one of the largest industrial sectors in the world and one which poses many challenges for government regulators; inefficient regulation would have costly implications for the environment, human health, government budgets and the continued growth of this important global industry. Not only can different regulatory approaches and requirements in each OECD country create significant costs for the chemicals industry and for governments, they can also create barriers to trade.

If national approaches to chemical regulation are harmonised, industry is not faced with a plethora of conflicting or duplicative requirements, governments are provided with a common basis for working with each other, and non-tariff barriers to trade are reduced. The principal tools for harmonisation are a set of OECD Council Decisions which make up the OECD Mutual Acceptance of Data (MAD) system, including its OECD Guidelines for the Testing of Chemicals and OECD Principles of Good Laboratory Practice (GLP).

 

Mutual Acceptance of Data

The MAD system helps to avoid conflicting or duplicative national requirements, provides a common basis for co-operation among national authorities and avoids creating non-tariff barriers to trade. OECD countries and full adherents have agreed that a safety test carried out in accordance with the OECD Test Guidelines and Principles of Good Laboratory Practice in one OECD country must be accepted by other OECD countries for assessment purposes. This is the concept of “tested once, accepted for assessment everywhere*”. This saves the chemicals industry the expense of duplicate testing for products which are marketed in more than one country. 

* While the receiving government must accept the study, how it interprets study results is its own prerogative. 

 

Did you know?

By reducing duplication, and creating a framework for the sharing of work, the MAD system saves governments and industry around €150,000,000 each year, as well as reduces the number of animals used in such testing.

 

MAD criterias for non-clinical health and safety test study

1. The study must have been conducted according to OECD Test Guideines and OECD Principles of GLP;
2. The study must have been conducted in a test facility which has been inspected by a national GLP compliance monitoring programme and;
3. The national GLP compliance monitoring programme must have undergone a successful evaluation by OECD.

If If all three criteria are met, all OECD member countries as well as adherents to MAD must accept the study data.

 

Which countries participate in the MAD system and to what extent?

All OECD member countries, as well as non-member provisional and full adherents, participate in MAD but to different degrees. As shown in the table below, the determining factor is whether a government’s national GLP compliance monitoring programme has undergone a successful OECD evaluation.

Yes

Country Successful OECD Evaluation The country must accept data from Full MAD Adherents and OECD members who have been evaluated by OECD All OECD members, Full and Provisional Adherents must accept data from them
OECD member countries   

OECD country
OECD country

Yes
No 

Yes
Yes

Yes
No

Non-member countries

Full adherent to MAD
Provisional Adherent to MAD

Yes
No

Yes
Yes

Yes
No 

A list of the status of each country which participates in the MAD system, can be found here. 
  

What is a GLP National Compliance Monitoring Programme?

In order for a government to be considered as a candidate for MAD, they must have a GLP Compliance Monitoring Programme (see OECD 1989 Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practice). This Programme is a particular scheme established by a government to monitor GLP compliance of test facilities within its territories, by means of inspections and study audits. The duties within this scheme are carried out by GLP Monitoring Authority, which is a body established by a government with the responsibility for monitoring the good laboratory practice compliance of test facilities within its territories and for discharging other such functions related to good laboratory practice as may be nationally determined.

What is the legal framework for the MAD system?

The multilateral agreement is composed of three OECD Council Acts (adopted by OECD ambassadors):

  • The 1981 Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals (revised in 1997) that states that test study data generated in any member country in accordance with OECD Test Guidelines and Principles of Good Laboratory Practice (GLP) shall be accepted in other member countries for assessment purposes and other uses relating to the protection of human health and the environment.
  • The 1989 Council Decision-Recommendation on Compliance with Principles of Good Laboratory Practices which establishes procedures for monitoring GLP compliance through government inspections and study audits as well as a framework for international liaison among monitoring and data-receiving authorities.
  • The 1997 Council Decision on the Adherence of Non-Member countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals that sets out a step-wise procedure for non-OECD economies to take part as full members in this system.