On June 1, 2007, the EU’s new chemical rules came into force. The new rules have been adopted as a regulation, which means that they have status of law in all member states from the date on which it came into force.
Basic principles of REACH
The new chemicals regulation is the most far-reaching legislation which the EU has ever passed, covering several thousand pages. It is therefore hard to explain in just a few words what it means for companies and for citizens, but the most important basic principles in relation to Cheminova’s business are the following:
Main purpose
Manufacturers and importers of chemicals must ensure that the products they produce or import do not have a negative impact on human health or the environment, while the companies that use the chemicals are under the same obligation.
Technical basis
To ensure that the chemicals do not have a negative impact on human health or the environment, it is necessary to conduct a number of complex assessments which are described in more detail in the regulation. Manufacturers and the importers are responsible both technically and financially for ensuring that these evaluations are conducted.
Deadlines
The chemical evaluations need to be carried out on thousands of substances, which means it will take a long time to complete them all. A deadline of 11 years has therefore been set, by which time the substance evaluations must have been carried out.
To ensure that the chemical evaluations are evenly spread over the 11-year period, shorter deadlines have been set for certain groups of substances. Thus, substances which are currently deemed to have a negative impact on human health or the environment will be evaluated within the next three and a half years. This deadline also applies to substances which are manufactured in large volumes (>1,000 tonnes per year). The next deadline is after 6 years, where substances that are manufactured in medium volumes (>100 tonnes per year) must be evaluated. The rest, substances which are manufactured in small volumes (>1 tonne per year), must be registered before the final 11-year deadline.
In the period June 2008 to December 2008, a pre-registration statement must be submitted to the authorities for each substance which the company wants to register in the above time period.
Relaxed rules for certain chemicals which are used internally in chemical companies
For chemicals called intermediates which are only used internally in chemical companies as “building blocks” for the manufactured substances, relaxed rules apply for the knowledge that must be procured. The reason for this is that these chemicals are kept in closed systems and only handled by people who are professionally trained for the task. These chemicals are thus not spread into the surroundings with the accompanying risk of affecting human health and the environment.
Consequences of registration
The chemical registrations will in by far the most cases result in a continued acceptance of the substances being used. However, some substances may only be used if they comply with certain restrictions, while individual substances may be banned for certain purposes or completely.
As registering of these chemicals is expensive, they may also disappear from the market if the earnings on these products are so low that no company could justify paying to have them registered.
Consequences for Cheminova as a manufacturer of chemicals
The company is very familiar with the term “registration of chemicals”, as 90% of the company’s revenue derives from plant protection products which are covered by “registration rules” in the countries where they are sold. These rules can vary significantly from one country to another. In the EU, there is a common set of rules for registering plant protection products.
 Active ingredients in plant protection products and accessory agents which are only used for plant protection products which are registered in the EU in relation to the plant protection product regulation, are also regarded as being registered in accordance with REACH. This means that most of the substances manufactured at the company in Denmark are already registered as stipulated in the new chemicals regulation.
The substances which must be registered in accordance with REACH in the coming years
Shipping area on Rønland. are confined to intermediates which are handled, a number of substances which are sold for use as flotation agents in the mining industry, and two plant protection products which are not registered in the EU. The following describes in more detail the substances which must be registered within the first deadline of three and a half years (see above), in other words before the end of 2010.
Intermediates
The technical knowledge required to register a substance consists of a summary of the company’s existing information about the substances as well as the material which is publicly available in databases and other similar sources. Thus, no special tests need to be carried out. At the company on Rønland, Cheminova handles eleven chemical substances which must be registered according to these relaxed rules before 2010.
If you sell an intermediate to another chemical company and in so doing transport the substance outside the company’s premises, and also produce more than 1,000 tonnes of this substance each year, a small number of specific tests need to be performed. These supplement the existing known information. Three of the above intermediates handled by Cheminova fall under this rule.
Flotation agents for the mining industry
All flotation agents are manufactured in volumes of less than 1,000 tonnes per year, so they do not need registering until after 2010 and are therefore not mentioned again in this report. Most of them must be registered before 2013.
Plant protection products
Cheminova manufactures three plant protection products which are currently not registered in accordance with the EU’s plant protection product regulation. These are methyl parathion, malathion and gamma-cyhalotrin. However, the substances are registered as plant protection products in a number of countries outside the EU, such as the US.
As a result of the lack of registration in the EU, methyl parathion and malathion must be registered in accordance with REACH, and as they are both manufactured in volumes exceeding 1,000 tonnes per year, this must happen before the end of 2010. Gamma-cyhalotrin is registered in accordance with the previous chemicals legislation and is therefore regarded as being registered, also in accordance with the present regulation.
The purpose of registering according to REACH is to ensure that the necessary knowledge about the two substances is procured so the activities that take place in the EU are safe. As far as the two substances are concerned, this will cover their production and transport. It also en-sures that knowledge about the substances is available which the authorities in the countries that wish to use them can use in their assessments.
However, the necessary data for the REACH registration have existed for some years after the two substances were registered as plant protection products in the countries where they are marketed. The data requirements for using the substances in the US have been particularly extensive.
Consequences for Cheminova as a consumer of chemicals
As described in the section “Main purpose”, see above, it is not just the responsibility of the manufacturer ensuring that a substance does not have a negative impact on human health or the environment. It is also the responsibility of companies using the substance. Consequently, when a company registers a substance, the knowledge procured must be passed on to all the customers buying the substance. The customers must then, in collaboration with the supplier, ensure that they use the substance without it damaging human health or the environment. If they cannot, the supplier must not sell the substance for the intended purpose.
The specific consequence of this for Cheminova is that all raw materials and other chemical substances which it uses must be assessed in conjunction with the suppliers. Based on the knowledge about the substance which is received from the supplier, Cheminova must document that the substance is used properly. If it is not possible to do so, the supplier must not sell the substance to Cheminova. This work should be carried out on an ongoing basis during the 11-year period, as and when the chemicals are registered.
Targets for 2008
- Pre-registration: Reporting the substances which Cheminova wants to register during the 11-year phase-in period.
- Registering the substances which Cheminova handles, which cannot be pre-registered (substances which are considered as new in relation to the regulation).
- Initiate compiling information and data for the substances handled by Cheminova which must be registered before the end of 2010.
- Communicating with suppliers and customers about the obligations for the business entailed by REACH.
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