viernes, 2 de noviembre de 2012

A poisonous nightmare

In many occasions, it is very useful to use references of popular culture to explain concepts and issues related to complex technical or legal matters, too intangibles to be easily understood for general public or non initiates.

Whenever someone ask me what the Instituto Nacional de Toxicología (National Institute of Toxicology and Forensic Sciences) is, I always dip into a reference of “CSI: Las Vegas” TV show… “Have you ever seen CSI on TV?... well, when they say ‘We've sent the evidence to toxics analysis’… in Spain, that analysis is made by the INT… and that’s the reason because it depends of Justice Department”.

The origins of the INT come from the last years of 19th century but its current name was regulated by a Decree of 10th of July of 1935 during the II Spanish Republic.

It was not until 1971 that the INT became the national reference centre in poisoning information. The Decree 1789/1967, of 13 July, on the reorganization of the National Institute of Toxicology prepared the way. It reoriented the services and resources and paved the road to start the race of the National Poison Information Service. Curiously, on article 45, that Decree says: "This information service will be completely free"... Obviously, those were different times....

The National Poison Information Service started his advising activity in 1971 with a highly valuable telephone call service, assisted by toxicologists and physicians, where anybody, with a simple phone call, may receive information of symptoms, remedies, antidotes and treatment indicated to intoxicating substances, an issue in which accuracy of knowledge and speed in applying it are always critical.

In 1983, Royal Decree 2816/1983 on washing products and Royal Decree 3360/1983 on bleaches intended that producers, importers and packers will disclosure full information, including quantitative composition of mixtures, to National Poison Information Service if they were “officially” demanded to do it.

In 1999, Royal Decree 770/1999 gave the matter another twist and declared mandatory the previous registration on the Service of every washing product intended to be sold to consumers and general public. All other chemicals may be voluntarily declared on Poison Service to improve safety uses and responds in case of emergency.

This status quo changes dramatically with Regulation 1272/2008/EC, of 16 December 2008, on classification, labelling and packaging of substances and mixtures… better kwon as CLP, which in article 45 says:

“Member States shall appoint a body or bodies responsible for receiving information relevant, in particular, for formulating preventative and curative measures, in particular in the event of emergency health response, from importers and downstream users placing mixtures on the market. This information shall include the chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects, including the chemical identity of substances in mixtures for which a request for use of an alternative chemical name has been accepted by the Agency, in accordance with Article 24″.

Consequently, the notification of information on hazardous chemicals to appointed bodies is, since CLP went into effect, mandatory. These appointed bodies in EU Member States can be Poisons Centres or other governmental authorities, but Spanish Authorities have officially declared the Spanish National Poison Information Service as the reference Poison Centre in Spain.

The main problem Spanish Poison Centre will confront is that its dimensions, calculated for a limited portion of the huge chemical market, must be reformulated and, obviously, financially supported.

The Spanish Service is not the only European Poison Centre that will have to change; in other countries the Poison Centres are only open to inquiries from the health service and not from the general public, like in the Netherlands and the United Kingdom. The creation of some new safety phrases like P311 “Call a POISON CENTER or doctor/physician” give them no other choice.

The Chemical Industry is accustomed to confront with new legal exigencies and it gladly accepts them when they may improve safety of its products handling. The legislation Spanish Government is preparing to regulate this severe change in the Service makes legal the need to charge fees to registrants, I think it is not necessary to emphasize that the change of a free service in a paid one never are good news for those committed to pay but there are another more concerning question.

The phone number of the National Poison Centre must be included in section 1.4 of SDS... the Poison Centre of the country where the chemical is being commercialised. It has no sense at all that a SDS written in Bulgarian, for example, includes the phone number of a poison service not assisted in Bulgarian... has it?

Well... let me explain my concern: One of our affiliated SME, among many others, sells its products in Spain, as well as in Portugal, France, Belgium, Netherlands, UK, Ireland, Germany, Italy and Poland.

Therefore, as a consequence of CLP Regulation, our dynamic and innovative SME must make the registration of its 110 commercial references in 10 different Poison Centres, in 7 different languages?... and pay fees for every process, of course.

Is ECHA aware of this?... Is not urgent to unify the registry in Helsinki and supply the National Poison Centres with information from there?.

Has anybody a better idea?

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