40
3 The Role of Legislation
product authorizations can be expanded, such as adding additional minor uses. In
cases where a serious risk needs to be managed, EU member states can also grant
emergency authorizations for the controlled use of a product for a maximum period
of 120 days.
To protect consumers from exposure to potentially harmful pesticides, Regulation (EC) No 396/2005 sets specific maximum residue levels (MRLs). These
values represent the highest legally tolerated concentration of a pesticide residue
that is allowed to remain on food or animal feed. MRLs are assessed and set by
EFSA considering both the toxicity of each pesticide and different diets so that all
demographics, including higher-risk groups such as children, are not exposed at
unsafe levels. MRLs are currently set for nearly 300 fresh food products and 1100
pesticides. Where no specific MRL for a pesticide is set, a default value of 0.01
mg/kg is used.
Since many different pesticides are in use, consumers can be exposed to mixtures
of pesticides that might result in cumulative effects on their health. This is known
as mixture toxicity, and research is ongoing to investigate how to adequately
consider this when assessing chemical risks. Chapter 6 introduces this topic further
and discusses how different chemicals can interact with one another. All active
substances and pesticide products currently in use in the EU, as well as their MRLs,
can be found online in the EU pesticides database (European Commission, 2019b).
3.3.4 Pharmaceutical Legislation in the EU
Pharmaceuticals are in many ways a very distinctive class of chemicals requiring
special attention to protect human health and the environment from unintended
adverse effects. In the EU, legislation addressing this topic is mainly set out
in Directive 2001/83/EC and Regulation (EC) No 726/2004, both of which are
centrally overseen by the European Medicines Agency (EMA) (EMA, 2019b).
Pharmaceutical companies according to EU regulation need to apply for authorization from the EMA to market a new drug. Before filing an application, they
inform the EMA about their intention to do so, and the EMA offers scientific
support in preparing the application to ensure that it complies with the legal and
regulatory requirements. This is largely intended to help applicants follow the
proper methodology and study design to efficiently generate robust data on the
effectiveness and potential risks of the medicine being developed. Potential future
patients are also often consulted to identify their needs (EMA, 2019a).
The application dossier needs to include information on the substance itself
(including molecular structure, physicochemical properties, stability, biological
activity), the drug’s effect on patients (including its mode of action, distribution and
elimination in the body, and side effects), as well as planned measures to monitor
and manage risks after the authorization of the drug. Weighing the benefits and
risks of the medicine, the EMA’s Committee for Medicinal Products for Human
Use (CHMP) will decide on the application within 210 days. During this evaluation
period, external experts with special scientific knowledge or clinical expertise are
3 The Role of Legislation
product authorizations can be expanded, such as adding additional minor uses. In
cases where a serious risk needs to be managed, EU member states can also grant
emergency authorizations for the controlled use of a product for a maximum period
of 120 days.
To protect consumers from exposure to potentially harmful pesticides, Regulation (EC) No 396/2005 sets specific maximum residue levels (MRLs). These
values represent the highest legally tolerated concentration of a pesticide residue
that is allowed to remain on food or animal feed. MRLs are assessed and set by
EFSA considering both the toxicity of each pesticide and different diets so that all
demographics, including higher-risk groups such as children, are not exposed at
unsafe levels. MRLs are currently set for nearly 300 fresh food products and 1100
pesticides. Where no specific MRL for a pesticide is set, a default value of 0.01
mg/kg is used.
Since many different pesticides are in use, consumers can be exposed to mixtures
of pesticides that might result in cumulative effects on their health. This is known
as mixture toxicity, and research is ongoing to investigate how to adequately
consider this when assessing chemical risks. Chapter 6 introduces this topic further
and discusses how different chemicals can interact with one another. All active
substances and pesticide products currently in use in the EU, as well as their MRLs,
can be found online in the EU pesticides database (European Commission, 2019b).
3.3.4 Pharmaceutical Legislation in the EU
Pharmaceuticals are in many ways a very distinctive class of chemicals requiring
special attention to protect human health and the environment from unintended
adverse effects. In the EU, legislation addressing this topic is mainly set out
in Directive 2001/83/EC and Regulation (EC) No 726/2004, both of which are
centrally overseen by the European Medicines Agency (EMA) (EMA, 2019b).
Pharmaceutical companies according to EU regulation need to apply for authorization from the EMA to market a new drug. Before filing an application, they
inform the EMA about their intention to do so, and the EMA offers scientific
support in preparing the application to ensure that it complies with the legal and
regulatory requirements. This is largely intended to help applicants follow the
proper methodology and study design to efficiently generate robust data on the
effectiveness and potential risks of the medicine being developed. Potential future
patients are also often consulted to identify their needs (EMA, 2019a).
The application dossier needs to include information on the substance itself
(including molecular structure, physicochemical properties, stability, biological
activity), the drug’s effect on patients (including its mode of action, distribution and
elimination in the body, and side effects), as well as planned measures to monitor
and manage risks after the authorization of the drug. Weighing the benefits and
risks of the medicine, the EMA’s Committee for Medicinal Products for Human
Use (CHMP) will decide on the application within 210 days. During this evaluation
period, external experts with special scientific knowledge or clinical expertise are