3.3 Product Legislation
37
• Precautionary statements: Similar to hazard statements, precautionary statements
must be included on the label to give more information on how to prevent or
minimize adverse effects on human health or the environment. Precautionary
statements also have a code, made up of a “P” followed by a three-digit number
indicating the category of precaution (see Table 3.2 and UN (2019) for the full
list).
• Supplemental labeling information: Under CLP, additional obligatory information to display on the label includes any EU hazard statements (codified as
“EUH” statements) and REACH authorization numbers.
To ensure visibility and readability, the CLP Regulation also specifies the size
and placement of the label on the package of a chemical product. Manufacturers
and importers must also submit the classification and labeling information to
the Classification and Labelling (C&L) Inventory of ECHA (ECHA, 2019h).
Information on hazardous substances and mixtures also needs to be provided to
poison control centers for them to be able to provide rapid medical advice in an
emergency.
Only substances and mixtures that are placed on the market fall under the CLP
Regulation, which means that it does not apply to non-isolated intermediates or
substances only used in scientific research. It also does not apply to radioactive
substances. Guidance documentation with further information about complying
with the CLP Regulation can be found on ECHA’s website (ECHA, 2019h).
3.3.3 Pesticide Legislation in the EU
Developed specifically for their toxic effects on target organisms, pesticides can
pose unintended yet significant risks to both human health and the environment. To
minimize such risks and reduce the overall dependency on the use of pesticides,
the EU introduced Directive 2009/128/EC on the sustainable use of pesticides,
Regulation (EC) No 1107/2009 on the approval of pesticides, and Regulation (EC)
No 396/2005 on the maximum amounts of pesticides allowed to be on or in food and
feed (European Commission, 2019c). In these pieces of legislation, the EU follows
a twofold approach: First, Directive 2009/128/EC sets out that the dependency on
pesticides should be reduced by promoting organic farming and integrated pest
management (IPM). The primary aim of IPM is to reduce pesticide use by promoting
alternative approaches and techniques to pest control, such as crop rotation, the use
of resistant plants, and natural biological and physical methods. If pesticides need
to be used, IPM stipulates applying reduced doses with high specificity. According
to the regulations, IPM must be implemented by all professional users of pesticides
in the EU.
Second, Regulation (EC) No 1107/2009 defines that all active substances used in
pesticides require approval. It also requires that all final formulated products (i.e.,
containing both the active and inactive ingredients) need to be authorized before
use. To seek approval for a novel active substance, manufacturers must apply to an
37
• Precautionary statements: Similar to hazard statements, precautionary statements
must be included on the label to give more information on how to prevent or
minimize adverse effects on human health or the environment. Precautionary
statements also have a code, made up of a “P” followed by a three-digit number
indicating the category of precaution (see Table 3.2 and UN (2019) for the full
list).
• Supplemental labeling information: Under CLP, additional obligatory information to display on the label includes any EU hazard statements (codified as
“EUH” statements) and REACH authorization numbers.
To ensure visibility and readability, the CLP Regulation also specifies the size
and placement of the label on the package of a chemical product. Manufacturers
and importers must also submit the classification and labeling information to
the Classification and Labelling (C&L) Inventory of ECHA (ECHA, 2019h).
Information on hazardous substances and mixtures also needs to be provided to
poison control centers for them to be able to provide rapid medical advice in an
emergency.
Only substances and mixtures that are placed on the market fall under the CLP
Regulation, which means that it does not apply to non-isolated intermediates or
substances only used in scientific research. It also does not apply to radioactive
substances. Guidance documentation with further information about complying
with the CLP Regulation can be found on ECHA’s website (ECHA, 2019h).
3.3.3 Pesticide Legislation in the EU
Developed specifically for their toxic effects on target organisms, pesticides can
pose unintended yet significant risks to both human health and the environment. To
minimize such risks and reduce the overall dependency on the use of pesticides,
the EU introduced Directive 2009/128/EC on the sustainable use of pesticides,
Regulation (EC) No 1107/2009 on the approval of pesticides, and Regulation (EC)
No 396/2005 on the maximum amounts of pesticides allowed to be on or in food and
feed (European Commission, 2019c). In these pieces of legislation, the EU follows
a twofold approach: First, Directive 2009/128/EC sets out that the dependency on
pesticides should be reduced by promoting organic farming and integrated pest
management (IPM). The primary aim of IPM is to reduce pesticide use by promoting
alternative approaches and techniques to pest control, such as crop rotation, the use
of resistant plants, and natural biological and physical methods. If pesticides need
to be used, IPM stipulates applying reduced doses with high specificity. According
to the regulations, IPM must be implemented by all professional users of pesticides
in the EU.
Second, Regulation (EC) No 1107/2009 defines that all active substances used in
pesticides require approval. It also requires that all final formulated products (i.e.,
containing both the active and inactive ingredients) need to be authorized before
use. To seek approval for a novel active substance, manufacturers must apply to an