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Chemical research etc.

Picture Chemical research

There are about 70 000 chemical substances on the market today. Chemical substances and preparations can be harmful to humans, animals and the environment. Therefore, these areas are safeguared by a number of laws and guidelines. The Swedish Chemicals Agency has regulations for chemical products and biotechnical organisms. From Arbetsmiljöverket, there are regulations for laboratory work using chemicals (AFS 1997:10), and chemical risks in the job environment (AFS 2000:4). The International Labour Organization is behind a Convention Concerning Safety in the Use of Chemicals at Work.

The Swedish Environmental Code's Chapter 14 addresses chemical products. In an addendum to this chapter are a large number of ordinances that in a more precise way regulate the handling of specific chemicals, for example the use of freon. The ordinance (SFS 1998:899) on environmentally dangerous work and health protection regulates when chemical or biological laboratories for research and development have a duty to report.

European Union

On the EU level we find various regulations on chemicals, industrial risks and biotech. The latest in this field is the Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), including the establishment of a European chemical authority. The new legislation has gradually come in force from June 2007. See also Article 17 on research in the European Parliament's and Council's Directive 98/8/EC concerning the placement of biocidal products on the market. The Swedish Enforcement and Regulations Council has a summary of legislation on chemicals containing both the EU's legal acts and Swedish regulations.

USA

Experiments that intentionally dose human subjects with pesticides and other chemicals are evaluated and approved by the U.S. Environmental Protection Agency (EPA) in a case-by-case manner. A recent U.S. Congressional report reviewing pesticide studies raised serious concerns about the intentional dosing of human subjects. The report finds that in each of the 22 studies reviewed, there were violations of ethical standards as set out by the National Academy of Sciences (NAS), the Nuremberg Code and other professional medical and scientific guidelines (Human Pesticide Experiments, June 2005, Prepared for Senator Barbara Boxer and Representative Henry A. Waxman, U.S. Congress). In the autumn of 2005, the US Congress put a one-year moratorium on using human tests to determine whether a pesticide should be marketed. Since that expired, tests are allowed but shall from now on adhere to EPA's Protections for Subjects in Human Research.

International standards

Internationally the OECD has published a number of codes in their OECD Guidelines for the Testing of Chemicals. The International Council of Chemical Associations (ICCA) has published a policy on risk based decision making and a policy for sustainable development. In Agenda 21, Chapter 19 contains guidelines for Chemical Safety. The International Conference on Chemicals Management (ICCM) adopted the Strategic Approach to International Chemicals Management (SAICM) in February 2006. The OECD's principles for Good Laboratory Practice (GLP) that have been recognized by the EU and put into practice in Sweden (STAFS 2008:4) also carry weight. See also the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade (PIC Convention), which is in force from the 24 February 2004 and includes the European Union among its parties.

Last updated: 2012-10-15

Rules & guidelines

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CODEX, Centre for Research Ethics & Bioethics, BMC, Husarg. 3, Uppsala | Webmaster | About the web site