Schraff

It could be a lot worse. The agrochemical industry and legislators quarreled for years over the language of the EU’s new rules for registering agrochemicals, and the compromise reached late last year will actually allow companies that do business in multiple member states to bring chemicals to market faster.

And the new evaluation criteria will probably result in about two-dozen lost chemicals versus the hundreds that could have been lost from the language in the bill’s first reading.

The compromise essentially means that no one group is ecstatic about the new rules. “If all parties at the end of the day complain, then it seems to me that we have a fairly balanced piece of legislation,” says Wolfgang Reinert, an officer with the European Commission’s unit of chemicals, contaminants and pesticides. He helped write the legislation with input from members of Parliament and industry, and he says the commission is satisfied with the compromise.

Members of the European Parliament overwhelmingly approved the directive concerning the placing of plant protection products on the market in January. The new rules are scheduled to take effect in 2010.

First, the good news: Registrants can bring chemicals to market quicker than before. It’s true, potentially. The streamlined administrative process results from the decision to split the EU’s 27 member states into three zones.

Under the new structure, a product must go through the registration process at the most three times — one for each zone — to be approved for use in the entire EU, instead of potentially being subject to 27 separate registration procedures. Early talks considered a one-zone administration, but members of parliament considered the measure too intrusive on member countries.

“We would have liked a one-zone concept, but we can live with a three-zone concept,” says Stephan Schraff, manager of governmental affairs for the European Chemical Pesticide Association, which worked closely with legislators to draft the new rules. “The crucial thing is that there will be an increase in work sharing between the member states and therefore more transparency between and trust in the judgment of fellow member states. We also think that there will be more standardization in the application forms and so on. So for these reasons and others, we support the zonal system.”

Reinert says the new system should foster better relationships among member states and help expedite the approval and process of chemicals and help deliver them to market faster, but most importantly, it will offer the approval process a greater degree of objectivity and fairness because of the necessary collaboration among member states.

“When you look at the current practice of granting authorizations by member states in more detail, and then you see that some registrations can be totally arbitrary,” Reinert says. “We are going to encourage the work sharing and give it a more stable format, and by the end of the day, we think the system will work, and cases will be taken much quicker because if you have a system of mutual recognition, then you won’t lose time with a second state making a full evaluation of the dossier again. We need to encourage member states to trust each other by working together.

”According to the new rules, registrants will apply for approval to a member state, and other member states within the zone must collaborate to approve or deny registration within 18 months. That’s a rigorous timeline compared to current schedules that can take up to four years in some instances.

The timeline might prove to be too much administration for some countries that might be understaffed or otherwise unwilling to meet the 18-month deadline, sources say, which means registrants might need to take a larger role in coordinating efforts between member states. The industry will have an additional burden determining price points as well.

“We go from 27 to three markets, which is a big step ahead,” Reinert says. “We think it could be a challenge for the industry because there are considerable price differences between member states for the same products or for products that are quite comparable. So pricing products appropriately will be a challenge in addition to building up new procedural structures that also reflect the requirements of the zonal system.”

Points Of Contention

While the new zone might be additional administration, the biggest burden to industry is the inclusion of endocrine disruption criteria in the new rule.

Although the temporary definition of endocrine disruptor likely will affect just 22 chemicals, it is the beginning of what the industry considers as the evaluation of chemicals using hazard-based criteria instead of risk-based criteria.

The difference is simple: a risk-based assessment considers substances in the context of dosages and relative application methods for which they are intended. In a hazard-based assessment, scientists only determine whether or not a substance can trigger a negative physiological response.

Endocrine disruptors, at this point, are defined as any substances that trigger Class 3 carcinogenic effects and Class 3 reproductive effects. If any chemical triggers these two criteria, then they will be labeled endocrine disruptors, and registration will not be renewed (see “Blacklisted”). Also, any Class 1 or Class 2 chemical will not be permitted, and any substance that triggers the Class 3 reproductive criteria and proves harmful to endocrine organs might be forbidden as well.

“The cut-off criteria are a major concern across the food sector,” says Sabine Hoffman, spokesperson for Syngenta. “The criteria could result in the loss of a number of active substances, which could undermine integrated pest management programs, food production and affordability.”

Although the EU will probably lose an estimated 5% to 15% of current actives, the language in the original rule was far more draconian.

More extensive hazard-based criteria existed in the first reading of the pesticide rules early last summer. The resultant outcry that the language could eliminate about 85% of all chemicals registered in the EU help industry succeed in shaping the new criteria. However, its implementation will be tricky and likely will result in the loss of some fungicides.

The two major classes of fungicides at risk are triazoles and dithiocarbonates, which could pose problems for cereal production in Europe, and it could require growers to apply more of less-active chemicals and take away resistance management tools.

“Triazoles are the backbone of the European cereal production in terms of our ability to control Septoria, which is the biggest disease in European cereals,” says Paul Leonard, corporate and government relations, crop protection for BASF. “Removal of the most-active triazoles would most likely require replacement by more intense and frequent use of less-active fungicides, which is a process that doesn’t help to win the war against fungicide resistance.”

The European Commission is required to write a permanent, scientific rule on how to identify and label a substance as an endocrine disruptor within the next four years. The current definition is widely viewed as a political compromise, one that not only might remove valuable substances from the market in the EU, but it also might inhibit the ability of basic manufacturers to bring new products to market without triggering the cutoff criteria.

“By making a political statement to ban before the science has been established on how to define the endocrine criteria means that we could be facing a wide range of possibilities down the road,” Leonard says. “That’s why we in the agricultural community are so concerned."