3.6 Room for Improvement
49
3.5
Regulatory Outlook
Legislation addressing chemical products and processes has been constantly developing. The earlier approach of introducing reactive legislation in response to
problematic products such as DDT has started to shift toward the introduction of
new legislation such as REACH in the EU that aim for a more proactive approach
in order to protect human health and the environment before a chemical enters the
market.
While this chapter introduces some of the fundamental legislation existing in
2020, changes and adaptations take place regularly. In the EU, assessments of
chemicals already on the market as well as chemicals to be introduced into the
market will continue for authorization and restriction. New amendments could
change the assessment procedures or data requirements, and entirely new pieces
of legislation might be developed to address risks posed by future technologies.
In the coming years, chemical legislation in Asia, South America, and Africa are
especially likely to continue expanding, and they could end up being sometimes very
similar to and other times very different from their European and North American
counterparts.
In that sense, staying up to date with the latest legislation is an ongoing task, and
companies often need to have entire regulatory affair departments to handle the legal
obligations for their multiple products that could enter many different international
markets. The websites of the regulations, agencies, and organizations referenced in
this chapter can serve as initial sources of information for staying informed.
3.6
Room for Improvement
Significant effort has gone into developing and implementing the chemical legislation that exists today. In the EU, significant numbers of stakeholders from
government agencies, companies and industry associations, civil society groups, and
many others were involved in complex discussions and negotiations over multiple
years to make this possible. While this is no doubt a commendable achievement,
there should always be room for reflection and continuous improvement. In that
spirit, there have been many recent efforts from various stakeholder groups to
identify recommendations to increase the protection offered and minimize the
administrative burden created by regulations.
For legislation in Europe, a few of the key discussion points and recommendations for improvement include the following:
• Of the REACH registration dossiers that are inspected by authorities, many
have been found to be incomplete or inaccurate. (ECHA, 2017; European
Environmental Bureau, 2019a,b; Oertel et al., 2018). ECHA has responded
through the creation of action plans to increase and improve inspections (ECHA,
2019g) and said that improving compliance is a priority (ECHA, 2019e). The
49
3.5
Regulatory Outlook
Legislation addressing chemical products and processes has been constantly developing. The earlier approach of introducing reactive legislation in response to
problematic products such as DDT has started to shift toward the introduction of
new legislation such as REACH in the EU that aim for a more proactive approach
in order to protect human health and the environment before a chemical enters the
market.
While this chapter introduces some of the fundamental legislation existing in
2020, changes and adaptations take place regularly. In the EU, assessments of
chemicals already on the market as well as chemicals to be introduced into the
market will continue for authorization and restriction. New amendments could
change the assessment procedures or data requirements, and entirely new pieces
of legislation might be developed to address risks posed by future technologies.
In the coming years, chemical legislation in Asia, South America, and Africa are
especially likely to continue expanding, and they could end up being sometimes very
similar to and other times very different from their European and North American
counterparts.
In that sense, staying up to date with the latest legislation is an ongoing task, and
companies often need to have entire regulatory affair departments to handle the legal
obligations for their multiple products that could enter many different international
markets. The websites of the regulations, agencies, and organizations referenced in
this chapter can serve as initial sources of information for staying informed.
3.6
Room for Improvement
Significant effort has gone into developing and implementing the chemical legislation that exists today. In the EU, significant numbers of stakeholders from
government agencies, companies and industry associations, civil society groups, and
many others were involved in complex discussions and negotiations over multiple
years to make this possible. While this is no doubt a commendable achievement,
there should always be room for reflection and continuous improvement. In that
spirit, there have been many recent efforts from various stakeholder groups to
identify recommendations to increase the protection offered and minimize the
administrative burden created by regulations.
For legislation in Europe, a few of the key discussion points and recommendations for improvement include the following:
• Of the REACH registration dossiers that are inspected by authorities, many
have been found to be incomplete or inaccurate. (ECHA, 2017; European
Environmental Bureau, 2019a,b; Oertel et al., 2018). ECHA has responded
through the creation of action plans to increase and improve inspections (ECHA,
2019g) and said that improving compliance is a priority (ECHA, 2019e). The