Shame! (Toxicology and clichés...)

It is very hard to fight against clichés. It is hard because our own perception can't be objective and it is fully oriented to confirm what we have previously learned. Our brain is very stubborn.

With clichés, this brain gear works even better. Along your daily life you may find tons of perfectly honest politicians but, if you ever find a crooked one, your brain makes you say: "All politicians are the same, everyone of them cheats".

Accidents statistics clearly say women drive cars better than men. The dishonest people rates are equal between lawyers, bankers and councilmen of urbanism than between average people but the cliché stored in the hard disk of our brains thinks in the opposite direction.

We have been working with transnational companies for years and, one of the clichés we have been fighting against is that one which says Spaniard are reckless, do not plan and try to fix everything in the last moment by improvisation.

After all this years participating in REACH's framework, we have seen similar level of efficiency among French, German, British and Spanish companies, engineering and consultancies.

We are still convinced but, some days ago, suddenly, our own Public Administration, the Spanish Public Service, stubbornly and surprisingly persisted in confirming the clichés... once again. And we, ashamed, only were able to try to explain to the corporate services of our affiliated companies the situation, trying not to use words as "blunder", "incompetent" or "absurdity", precisely, avoiding confirming the cliché.

We started very early insisting our companies to move forward with the procedures before the National Institute of Toxicology. In January, 2002, we sent this circular  letter explaining that time procedures and advising: "It is foreseeable that, given the resources available to the SIT and the avalanche of registration applications in case this obligation is incorporated, AVEQ recommends that all marketed products be registered as soon as possible"

We have seen all predictions we made have been fulfilled one by one and, 15 year latter, the process was going to culminate last June, 1st, with the coming into force of the compulsory registration of all industrial mixtures classified as dangerous. Thousands, maybe millions, of formulas, with their SDSs and labels, should have been uploaded with the on-line application created ex-profeso for this purpose. We, and all the industry with us, had the premonition that the application was going to colapse at the precise moment.

But the “colapse”, the real “colapse”, the true and genuine Spanish blunder came, two days before the end of the term when…  maybe, better, I’ll let Borja Fernández Almau, our Product Stewardship Manager explain it, pasting one of the email he was forced to write. This one sent to an important Italian chemical company:


Hello Giovanna, let me try to explain the unintelligible legal situation we are suffering here and see the options we have.

Approximately a couple of months ago, the National Institute of Toxicology, Spanish anti-poison centre (INTCF) changed its management; apparently, the new director joined in with the concern of not being able to handle an expected massive number of registrations. Last Tuesday, May 30th, we received from FEIQUE (Spanish Chemical Industry Federation) a draft regulation where a modification of the obligation to register was proposed as follows: whereas for hazardous mixtures for consumer or professional use the same conditions and deadlines prevail, for industrial mixtures there is a delay in the obligation to register up until 2024.

This delay is not automatic for every product, a kind of "pre-registration" is required to adhere to the new deadline; this simplified procedure requires sending the SDS and the label (not composition nor other data). Besides, no fees are to be paid.

So, for your legal entity in Spain there is no choice, as long as the applications were filed, the fees paid and the registration numbers assigned the procedure is already closed, but for your company in Netherlands, we still can choose, there are two options:

- We finish the process: We could upload the fee receipt you sent yesterday, so the mixtures will be fully registered (and the INTCF telephone can be used in your SDS). Main problem is that you are supposed to update the sheets in case of modifications.

- We stop the process of registrations: We are still on time to cancel the applications not uploading the fee receipts. We could ask the fees to be reimbursed and then we would send the SDS and labels through the simplified registration. In this case you save the fees but we will be in a non-compliance situation till the new regulation come into force.  The draft regulation is still under consultation, its approval is expected by the end of this month. In any case, taking under consideration that the Ministry is making a whole mess out of this matter, I am unable to assure the achievement of these deadlines.

Let me know your thoughts,
Borja


As summary: all diligent producers, not have only paid the fees for nothing, they will have to pay fees for every modification they’ll make in their formulas for the next seven years. Whoever has looked the other way, whoever had been negligent, will have seven years more of tranquillity… Once again, due the Spanish clichés serious companies lose, crooked companies win.



Back to: www.aveq-kimika.es

Is it worth being a member of AVEQ-KIMIKA?

One of our leading affiliated companies has been recently acquired by one of the most innovative transnational corporation of the European Chemical Industry... it is obvious that, with every acquisition, all management procedures are revised and, of course, every charge and every cost are questioned. This time is not different than other.

Some days ago, the plant manager, client and friend for years, sent me an email with a longer explanation but may be easily condensed in two simple questions about our quarterly charge, made by her new supervisors:

Is this a mandatory requirement to have this?
If not mandatory what benefit do we get from having this?  

The first question is easy to answer: no, absolutely not.

The second one... well, I'll try:

1st. Today, every industrial project needs legal advice on environmental and safety regulations. It has to cover, not only wide scope in European and Spanish law, in our particular organization as a "federal state", advisors need to be particularly familiar with autonomous legislation and with administrative procedures of authorities.

2nd. Industrial companies in the Basque Country use to have very good technicians on their staff (chemists, engineers...)  but they have no lawyers specialized in environment and safety, basically because they do not need lawyers full time. What they do need is direct access to legal advise on this matters, agile and fast as necessary: ​​with just a call or an e-mail they can avoid many ulterior very serious problems. It is not just the information, what really matters is the quality, the quantity, enough but not exceeding, and the speed in the reception.

How? ... very easy: hire one (... or seven, as in our case, and a chemical engineer specialized in Seveso and emergency plans) shared between several companies with the same needs ... and, well, that is an "association".

3rd. Because AVEQ-KIMIKA services have emerged from the own associated companies and everything is designed with supervisor of affiliated professionals... All in AVEQ KIMIKA is designed to save the scarce resource in today industries: working time.

4th. Because AVEQ-KIMIKA have direct access to the Basque Government. In areas, such as environment and safety, is becoming increasingly important to have legal support in making decisions and to quickly consult with the regional administration, which holds virtually all powers in these matters.

5th. Because it's important not to feel alone and each of our meetings has a therapeutic component. Because many industries lost a lot of opportunities for not collaborating with other companies with problems (and solutions) similar to their own.

The huge variety of products that companies affiliated to AVEQ-KIMIKA produce, for a wide range of different markets, makes competition within the Association very rare, allowing all meetings and collaborations between companies open and instructive. Companies with shared concerns talk to each other without major problems.

6th. Because the law applicable to the industry is becoming more complex, more intricate and difficult ... and will go further in the future.

7th. Because the labor agreement applied to chemical companies in Spain is especially difficult. The General Convention of Chemical Industry is a particularly complex text. In AVEQ-KIMIKA we have the best law team of the Basque Country in knowledge and enforcement of this particular law.

8th. Because we are specialized in industrial communication and help our businesses to engage with their communities, neighbors, municipalities ...

9th. Because we know firsthand the most complex regulations to which the industry is facing since the first draft appears and we work on them before they are published in any official gazette: Seveso, IPPC, REACH, CLP-GHS, Environmental Responsibility, ADR...

10th. And ... .. because we are the best, what the hell... someone had to say it!

Back to www.aveq-kimika.es

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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How far is Helsinki from Alonsotegi?

"Do not judge and you will not be judged"... specially when almost everybody is trying to do theirs best in an as dificult matter as REACH Regulation. And, in any case, I always try to evaluate intentions more than results.

I introduce the entry this way because the concern I am going to talk about today may be misunderstood as a critic directly launched against some members of the technical staff of European Chemical Agency (ECHA) and this is not what I mean. I have had the privilege of meet some of them, working side by side with a few, and they all are highly skilled technicians and, the most of them, very good people.

However, the main problem of the Agency is that Helsinki is far, very far away from Alosotegi... from Alosotegi and from every place where European small and medium sized enterprises try to keep their store shutters open.


On 23rd April ECHA convened a "webinar" called "Downstream User Obligation". This kind of communication tool is a great way to transmit information and guidelines from the ECHA to the industry. Is an instrument to realize that feedback, the questions and concerns of the users are taken into account. If you have a time, conect the speakers and follow the presentations. They are very instructives.

In this very ocasion, after a good amount of information, the last item was an interesting briefing called "Frequently Asked Questions; Conclusions" presented by Bridget Ginnity and Augusto Di Bastiano.

One of the questions really caught my attention. A question we have been working in AVEQ-KIMIKA for months and we haven't been able to solve...  "We supply the substance in mixtures. What should we inform customers of and how?"

Of course we have the tool. The main instrument "pre" and "post" REACH to transmit the necessary information all along the supply chain is the Safety Data Sheet (SDS) but, with REACH Regulation fully in force, it will be accompained with a new document called Exposure Scenarios (ES) describing the conditions of use of the classified chemicals subtances to ensure a safe and balanced operational conditions regarding safety, health and environment.

REACH Regulation is... What would be the appropriate word?... a little bit ¿naive? about this issue: On Article 31. Requirements for safety data sheets it just says:  "Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses." "Relevant"?....  What is the scope of "relevant" in this context?... AVEQ-KIMIKA's role is to explain this question to SME.

To date we have not been able to find a balanced answer... and, therefore, the role played by the technicians of this kind of companies, in spite of all our effort, is so disproportionate, so out of scale, that the goals of all REACH system may be directly thrown to trash can and push many motivated SME to work under the law.

Suddenly, seeing the question in the presentation, we saw light at the end of the tunnel. Unfortunately, our joy lasted very little.

The answer of ECHA to the question was, in a home made transcription: "Don't run, we are working on it. We will release a specific guide about this specific matter in the coming months but the solutions will be sure in the development of this three guidelines:

• Incorporate information on the conditions of use into the main body of the SDS

• Develop exposure scenarios for your mixtures, which describe the safe use. This replaces the exposure scenarios provided by your supplier

• Forward the supplier exposure scenario for single substances in the mixture that are relevant to your customers

Well... let's translate this advices to Alonostegi's language and  let's start by the third option: 

"Forward"... a word that is going to be very popular in coming months. Just forward?:


"One of our best selling product is a mixture, a protective coating, incorporates five chemical substances. The ES of each SDS of this five components takes, more or less, 120 pages. If we just forward our suppliers exposure scenarios to our clients by mere adition... our own attached document will take 600 pages... My average client is a freelancer painter with no more than two or three employees... What the hell is he going to do with that mess?"

Well, let's try the second one: "Develop your own exposure scenarios" 

"How long does it take to develop an ES?... we have 350 different references in our catalog. Except 10 of them, which are substances that we buy in bulk and we repack, the rest are mixtures..."

Finally, the first option: "Incorporate information on the conditions of use into the main body of the SDS" 

"Oh!, We can do that!. That's what we have been doing, more or less, for years... Let's roll up our sleeves and start with the task, we have to review 350 SDS but it may be affordable... Wait a moment, what the hell is a PROC8 and an ECETOC TRA?"

On May, 1968, the walls of the Quartier latin of Paris were covered with graffiti. One of the most cited, full of romantic spirit and revolutionary poetry says: "Soyez realiste, demandez l'impossible"... it is a great motto but it can't become the ECHA's motto.

Mr Di Bastiano, we are going to follow your advice, we are going to wait patiently until the publication of the official guide. For your part, in that guide redaction, I would ask if you could take into account that SMEs are a large percentage of European industry and that an hour of work in an SDS is a fixed cost?

Thank you for your attention and congratulations for the webinar. It was a great job.

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The greatnesses and miseries of the European Union (peace and translation of MSDS)

Not everybody is aware that on May, 9th is celebrated the Day of Europe. It is the anniversary of the "Schuman Declaration" made in Paris in 1950.

That day, against the background of the threat of a new World War, a few month after Berlin blockade by the USSR, the French Foreign Minister Robert Schuman read to the international press a declaration calling France, Germany and other European countries to pool together their coal and steel production as "the first concrete foundation of a European federation": the European Community of Coal and Steel (CECA).

The declaration, written principally by Jean Monnet, that later became first president of CECA, declares in its very first lines what is the main goal of the whole european project: avoid Europe falling in another war, as it had been happening every 30 or 40 years since the Middle Age.

He said: "La contribution qu'une Europe organisée et vivante peut apporter à la civilisation est indispensable au maintien des relations pacifiques" (The contribution which an organized and living Europe can bring to civilization is indispensable to the maintenance of peaceful relations).

Along this 62 years, in the media or in the public opinion has been very easy to read or hear declarations about "the failure of Europe" or "the failure of the European Union". The alibi to such kind of declarations has changed along the years. It may be the Margaret Thatcher speech "No. No. No" in the House of Commons in 1990, the non-acceptance of the European Constitution by France in 2005 or nowadays the debt crisis of the Euro zone. But in front of such stuff, small stumbling in a long way, we can be proud to say that the menace of war in Europe never has been so far than in our days.

Robert Schuman, French Foreign Minister, was born German. He was born in Luxembourg but his roots where located in Metz, his hometown, in the disputed territory of Lorraine.

He was born German, and made the first World War as German, because Lorraine become part of the German Reicht for 47 years, between the armistice of the Franco-Prussian War and the armistice of the Great War.

Robert Schuman, Jean Monnet and the rest of the oficially declared "founding fathers" of the European Union: Konrad Adenauer, Winston Churchill, Alcide de Gasperi, Paul-Henri Spaak, Walter Hallstein and Altiero Spinelli understood that over almost every thing, people came together by commerce.

And "commerce" may be understood as a very comprehensive matter because almost every aspect of human life is affected and, in the other hand, affects to trade competition, its equally and fairness.

One of the most challenging piece of legislation araised by the European Union to rule trade in recent times has been Reach Regulation, that came into force on June, 1st, 2008. The main aims of such regulation is to ensure high level of protection of nature and human health from the risk that can be posed by chemicals... and promote the free circulation of chemicals within the European Union, and enhancing the competitiviness and innovation of Chemical Industry, one of the main pilars of European trade, economy... and employment.

In this last vector, in employment, the importance of the big amount of SMEs in European Chemical Industry worth to be taken with a little bit more of tenderness. The Directive, very ambitious in aims and scope, seems has forgotten to think over them and ignores the diference between fixed cost and variable cost, and how the competitiviness of SMEs, in front of the big transnational companies, critically depends of a controled ratio of fixed cost per tonne.

But let me present you an example. The challenge that European small and medium sized enterprises are confronting nowadays. Something that is a very minor problem for a big company producing millions of tonnes per year but a serious issue for small bussiness.

------

Hello Luis.

Listen, do you have any reference of any company dedicated to translating safety data sheets (MSDS with the exposure scenarios) into French, German and Italian? We have them in English, from the consortium, and we've already made translation into Spanish but we have some customers in France, Germany and Italy.

How much would be the budget to translate 20 MSDS with 30 or 40 pages each? ( Please find attached a sample).

Greetings and happy new year.

-----

Hello Javier,

Let me explain how we have organized this issue and the rates we have found for this service.

Since the start of the deep reviews of the MSDS and the onset of exposure scenarios, we have had constant demands for translation assignments ... but mainly translations from English to Spanish.

In the market, we found technical translation rates in wide range with diferent prices depending of languages,tariffed by words ... the problem is that the results of some of this translations have not been satisfied and reviews we've done of the work performed by professional translators have had to be some depth.

Furthermore, given the fact that translate scenarios is actually simpler than it seems. Whenever you are familiar with the document and you know how it is structured so that, despite being much longer in reality the effort to translate it is considerably less.

The rates we have seen in the market by professional translators, applied to the sample you sent me, 3818 words for MSDS and  9981 words for scenarios would leave these figures:

	Lowest bid (€/word)	MSDS words		Scenarios words		TOTAL
French	0.06	3818	229.08 €	9981	598.86 €	827.94 €
Italian	0.08	3818	305.44 €	9981	798.48 €	1103.92 €
German	0.09	3818	343.62 €	9981	898.29 €	1241.91 €
					Total	3173.77 €

3173.77 € x 20 MSDS = 63.475,40 €

After thinking a lot about it and make a couple of experiments, we decided that knowledge about REACH, CLP, and the MSDSs themselves are far more important than knowledge of language and that Borja and I, with our knowledge of English, French, German, Italian and Portuguese, are able to do the translation and then, included in our price, sent them to a professional translator to review the style and grammar. 

We are able to do a technically correct translation and more than enough to understanding but, especially in German, we prefer to review them and avoid failing in a declination or make a misspelling.

Since we only translate MSDS and scenarios, we decided not tariffed by words and apply a standard price because, in addition, the MSDS and the scenarios are very similar in all companies. 

In short, we charge 400 € per MSDS/ language and 250 € more for the scenario.

I'm very sorry but we haven't been able to find a sure enough but cheaper way to address this matter.

Kind regards

-----

Jean Monnet had a story of that momentous May 9th, that explains clearly how the declaration itself was a bet on the future:

Robert Schuman, who was in a hurry to take the train to London, skillfully dodged specific questions about the future of his plan from the journalists in his way out of the palace of Quai d’Orsay, site of the Minister,  until one of them exclaimed: "So this is a leap into the unknown?". "That is" replied Schuman confidently "a leap into the unknown" 

When our SMEs start his journey into de REACH process they where only sure of one thing: it was a jump into the future, it was a leap into the unknown... we only can hope present European authorities have a vision as correct as Schuman and Monnet had in that time, and they are aware that competitiveness increases with the rise of supply, not with its reduction. 

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Biomaterials, compost and biodegradation of single-use bags

Every year, more o less by the end of my annual holidays, I reach the same conclusion: Writing a blog is not a matter of time but of discipline. Every year I start my holidays planning to upload 3 entries every week… but my summer activities do not allow me… they are much more interesting than preaching about environment, safety, REACH or IPPC.

This year I have made something new, fifty per cent business and fifty per cent pleasure. I met Lucia Castro Díaz in Santiago de Compostela, one of those days of Santiago’s true weather, raining softly and quiet. We had talked through Internet many times and we share many worries and interests, but last Monday was the first time we met personally. We had breakfast in a café in the very heart of Santiago’s old quarter, in Rua del Vilar, at 08:30 am, when tourists haven’t already waked up and on streets you just can see some early birds peregrines, wearing their back bag and trekking boots.

Lucia got a Dphil in Materials at the Oxford University. Her thesis was about degradation of Polyethylene exposed to environment and, although her professional skills are deployed in a wide range of matters, she is a very specialist in polymeric materials.

As you can guess, we talked about many matters, I can’t avoid my natural curiosity and whenever I have the opportunity to talk to people “who knows” I ask for advice in matters I am concerned about.

In this occasion, what I was wondering about is the meaning of the Second Additional Provision of Law 22/2011 of 28 July, waste and contaminated soils: Replacing single-use bags.

The Provision dictates the complete ban of single-use bags “non biodegradable” in Spain by 2018 and declares that for the purposes of this rule the definition of “Biodegradation” shall be applied is those included in the norm EN 13432:2000 "Requirements for packaging recoverable through composting and biodegradation- Test scheme and evaluation criteria for the final acceptance of packaging"

My concern was specifically about the term "biodegradable", term of very common use, easily and usually misuse to confuse or at least to "distract".

The Spanish law, once again, makes the mistake of include the version year in the statement of the norm. The norm may be revised any given year and that number will change… omitting that data, the quote is equally correct and avoid any future confusion… but, any way, the European norm EN 13432 resolves the definition of “biodegradable” by defining the characteristics a material must own in order to be known as "compostable" and, therefore, recycled through composting of organic solid waste.

In fact all materials are, one way or another “biodegradables”, is just a matter of time elapsed. A steel beam may need hundred of years to disappear by the effect of environment but it will do it for sure. It is obvious that steel is not a biodegradable material… How quick must degradation of a material be to be considered as “degradable”?

One of the most elemental principles of chemistry announced by Antoine Lavoisier says “Rien ne se perd, rien ne se crée, tout se transforme”, “Matter can neither be created nor destroyed, only transformed” (Traité Elémentaire de Chimie, 1789). Every transformation has a result. If we destroy plastics in a blender we are able to “degrade” the material in minuscule particles but it is obvious that this “plastic powder” is not degraded enough to be released in environment… How small must be the result of degradation?

In my modest opinion, “compostable” is one step beyond “biodegradable” and something may be biodegradable and may not be able to reach quality enough to be useful in agriculture as compost. A biodegradable material is not necessarily compostable, because it must also disintegrate during the composting cycle. On the other hand, a material which breaks during composting into microscopic pieces which are then not fully biodegradable it is also not compostable, but EN 13432 is clear aligning both meanings.

The description of the compostability criteria is vital because materials not compatible with composting can decrease the final quality of compost and make it not suitable for agriculture and, as a result, commercially not acceptable. In fact, this norm is a reference point for the producers of compost.

According to the EN-13432, the characteristics of a compostable matter are:

"Biodegradability", understood as the capability of the compostable material to be converted into CO2 under the action of micro-organisms. This property is measured with a laboratory standard test method under EN-14046 (Packaging. Evaluation of the ultimate aerobic biodegradability and disintegration of packaging materials under controlled composting conditions. Method by analysis of released carbon dioxide). In order to show complete biodegradability, a biodegradation level of at least 90% must be reached in less than 6 months.

"Disintegrability" or fragmentation and loss of visibility in the final compost (absence of visual pollution). It is measured in a pilot scale composting test under EN-14045 (Packaging. Evaluation of the disintegration of packaging materials in practical oriented tests under defined composting conditions). Specimens of the test material are composted with biowaste for 3 months. The final compost is then screened with a 2 mm sieve. The mass of test material residues with dimensions> 2 mm shall be less than 10% of the original mass.

Absence of negative effects on the composting process. Verified with the pilot scale composting test and, finally, low levels of heavy metals.

Each of these points is considered necessary for the definition of compostability but it is not sufficient alone.

The first question that arises is: Spanish Law aims than by 2018 all single-use bags will be completely compostable or fulfilling the definition of biodegradable included in EN-13432 may be enough? (The quality of compost, and specifically the amount of heavy metals, is key in this matter).

The second one, the question I made to Lucia, is: Is there any material in market with quality enough to be useful as single-use bags that fulfill all compostability criteria included in EN-13432?... I doubted it.

I am going to take out my crystal ball once again: I think that, except revolutionary changes in materials, market is not going to accept single-use bags capable of fulfill neither the definition of biodegradable neither the complete compostability criteria and consumers will opt for multiple-use bags…. But, then, a new question springs… How many “uses” of a bag are necessary not to be considered as “single-use”?... Are two "uses" enough?.. are 15 "uses" enough?... ANAIP is very clear about that point, and so do is AENOR.

But… can anyone be completely sure what a consumer is going to do with a plastic bag intended to be multiple-use?... well, I can’t… What do you think?... Lucia, any advice?


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Hans Rosling and the magic washing machine

Thanks to JL Salgado and the web site “Fogonazos” I’ve just discovered this presentation.

The presenter is Hans Rosling, a Swedish medical doctor, teacher of International Health, co-founder of the Gapminder Foundation and a superb speaker. Among his merits is the lead of the fight against Konzo disease in rural parts of Africa for twenty years… when he talks about poverty he really knows what he’s talking about… he is not some kind of upstart.

Gapminder Foundation developed the Trendalyzer software system. An amazing way to present data of development by countries… and, as they say in their own web: “Fighting the most devastating myths by building a fact-based world view that everyone understands.”

Please, take 9 minutes to hear it… to understand his optimistic view of development and the contradictions we fell in when we try to impart lessons about poverty, comfortably seated in the armchair of our warm living room… it’s called: “Hans Rosling and the magic washing machine”




The transcription:

“I was only four years old when I saw my mother load a washing machine for the very first time in her life. That was a great day for my mother. My mother and father had been saving money for years to be able to buy that machine. And the first day it was going to be used, even Grandma was invited to see the machine. And Grandma was even more excited. Throughout her life she had been heating water with firewood, and she had hand washed laundry for seven children. And now she was going to watch electricity do that work.

My mother carefully opened the door, and she loaded the laundry into the machine, like this. And then, when she closed the door, Grandma said, "No, no, no, no. Let me, let me push the button." And Grandma pushed the button, and she said, "Oh, fantastic. I want to see this. Give me a chair. Give me a chair. I want to see it." And she sat down in front of the machine, and she watched the entire washing program. She was mesmerized. To my grandmother, the washing machine was a miracle.

Today, in Sweden and other rich countries, people are using so many different machines. Look, the homes are full of machines; I can't even name them all. And they also, when they want to travel, they use flying machines that can take them to remote destinations. And yet, in the world, there are so many people who still heat the water on fire, and they cook their food on fire. Sometimes they don't even have enough food. And they live below the poverty line. There are two billion fellow human beings who live on less than two dollars a day. And the richest people over there -- there's one billion people -- and they live above what I call the air line, because they spend more than $80 a day on their consumption.

But this is just one, two, three billion people, and obviously there are seven billion people in the world, so there must be one, two, three, four billion people more, who live in between the poverty and the air line. They have electricity, but the question is, how many have washing machines? I've done the scrutiny of market data, and I've found that, indeed, the washing machine has penetrated below the air line, and today there's an additional one billion people out there who live above the wash line. (Laughter) And they consume more than $40 per day. So two billion have access to washing machines.

And the remaining five billion, how do they wash? Or, to be more precise, how do most of the women in the world wash? Because it remains hard work for women to wash. They wash like this: by hand. It's a hard, time-consuming labor, which they have to do for hours every week. And sometimes they also have to bring water from far away to do the laundry at home. Or they have to bring the laundry away to a stream far off. And they want the washing machine. They don't want to spend such a large part of their life doing this hard work with so relatively low productivity. And there's nothing different in their wish than it was for my grandma. Look here, two generations ago in Sweden -- picking water from the stream, heating with firework and washing like that. They want the washing machine in exactly the same way.

But when I lecture to environmentally-concerned students, they tell me, "No, everybody in the world cannot have cars and washing machines." How can we tell this woman that she ain't going to have a washing machine? And then I ask my students, I've asked them -- over the last two years I've asked, "How many of you doesn't use a car?" And some of them proudly raise their hand and say, "I don't use a car." And then I put the really tough question: "How many of you hand wash your jeans and your bed sheets?" And no one raised their hand. Even the hardcore in the green movement use washing machines.

(Laughter)

So how come [this is] something that everyone uses and they think others will not stop it; what is special with this? I had to do an analysis about the energy used in the world. Here we are. Look here, you see the seven billion people up there: the air people, the wash people, the bulb people and the fire people. One unit like this is an energy unit of fossil fuel -- oil, coal or gas. That's what most of electricity and the energy in the world is. And it's 12 units used in the entire world, and the richest one billion, they use six of them. Half of the energy is used by one seventh of the world's population. And these ones who have washing machines, but not a house full of other machines, they use two. This group uses three, one each. And they also have electricity. And over there they don't even use one each. That makes 12 of them.

But the main concern for the environmentally-interested students -- and they are right -- is about the future. What are the trends? If we just prolong the trends, without any real advanced analysis, to 2050, there are two things that can increase the energy use. First, population growth. Second, economic growth. Population growth will mainly occur among the poorest people here, because they have high child mortality and they have many children per woman. And [with] that you will get two extra, but that won't change the energy use very much.

What will happen is economic growth. The best of here in the emerging economies -- I call them the New East -- they will jump the air line. "Wopp!" they will say. And they will start to use as much as the Old West are doing already. And these people, they want the washing machine. I told you. They'll go there. And they will double their energy use. And we hope that the poor people will get into the electric light. And they'll get a two child family without a stop in population growth. But the total energy consumption will increase to 22 units. And these 22 units still the richest people use most of it. So what needs to be done? Because the risk, the high probability of climate change is real. It's real. Of course they must be more energy efficient. They must change behavior in some way. They must also start to produce green energy, much more green energy. But until they have the same energy consumption per person, they shouldn't give advice to others -- what to do and what not to do. (Applause) Here we can get more green energy all over.

This is what we hope may happen. It's a real challenge in the future. But I can assure you that this woman in the favela in Rio, she wants a washing machine. She's very happy about her minister of energy that provided electricity to everyone -- so happy that she even voted for her. And she became Dilma Rousseff, the president elect of one of the biggest democracies in the world -- moving from minister of energy to president. If you have democracy, people will vote for washing machines. They love them.

And what's the magic with them? My mother explained the magic with this machine the very, very first day. She said, "Now Hans, we have loaded the laundry; the machine will make the work. And now we can go to the library." Because this is the magic: you load the laundry, and what do you get out of the machine? You get books out of the machines, children's books. And mother got time to read for me. She loved this. I got the "ABC." This is where I started my career as a professor, when my mother had time to read for me. And she also got books for herself. She managed to study English and learn that as a foreign language. And she read so many novels, so many different novels here. And we really, we really loved this machine.

And what we said, my mother and me, "Thank you industrialization. Thank you steel mill. Thank you power station. And thank you chemical processing industry that gave us time to read books."

Thank you very much.

(Applause)”

When words matter

Thomas H. Huxley, English biologist, one of the fathers of the modern science and great defender of Charles Darwin’s Theory of Evolution, once said: “A world of facts lies outside and beyond the world of words”… his public debate with Samuel Wilberforce in 1860, bishop in the Church of England, was a key moment of the global acceptance of the Evolution Theory and opened the door to a new step in human knowledge.

When he pronounced this famous quote his was not thinking in European Union, he was not thinking in REACH Regulation nor in law… but the sentence fits like a glove with an issue that we have been arguing about last weeks.

Let’s quote REACH Regulation:

ANNEX II - GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS

1.3. Company/undertaking identification

Identify the person responsible for placing the substance or preparation on the market within the Community, whether it is the manufacturer, importer or distributor. Give the full address and telephone number of this person as well as the e-mail address of the competent person responsible for the Safety Data Sheet.


In fact, we didn’t place much attention on this particular paragraph. We have always understood that Safety Data Sheets (SDS) and labels of chemical products must present the identification of the person (in most of cases “legal person”) responsible of placing on the market of the substance or mixture.

It is remarkable the difference showed by REACH in this paragraph when referred to “person responsible”, that must be fully identified and “competent person responsible for the SDS”, role that only a “natural person” is able to take on.

This difference is also visible in Spanish translation (“Se identificará al responsable de la comercialización” vs “la persona competente responsable de las FDS"), in French (“Identification du responsable de la mise sur le marché de la substance” vs. “la personne chargée de la fiche de données de sécurité”) and in German („Zu nennen ist die Person, […] für das Inverkehrbringen […] verantwortlich ist“ vs „sachkundigen Person, die für das Sicherheitsdatenblatt zuständig ist“).

At this point, things were, more or less, quite clear.

When producer and responsible of placing on the market of a chemical product is the same person the question becomes irrelevant. But when it is placing on the market through distributors, things turned a little bit more complex.

We have seen chains of distribution where labels and SDS are not replaced and clients have full knowledge of the original producer of chemical products. In this cases, original producer is liable of the information content on labels an SDS, and will have to confront tort or any other way of assume liability in case of accident derived of mistakes or lacks of information.

In other chains of distribution, there are intermediate packers: companies buying chemical products in big amounts and re-pack then in smaller sized containers. A typical business is buying complete tankers of 32.000 litres and selling IBCs of 1 tonne. In this kind of distribution procedure, “re-packer” uses to change labels and SDS taking over liability and becoming “the person responsible for placing on the market”.

Another variation of this chain is when, for commercial reasons, distributors want to keep on secret to his clients who is the true producer of the chemical product although he merely replace labels and SDS in the own container of the original producer, he not even open the container. This kind of behavior is very common in markets like washing products for hospitality sector, bars, restaurants and hotels. Distributors become likewise responsible of placing on the market.

Roles were clear, and that’s the point, that’s what truly matter in this mess: the role assumed by any participant in this business and liabilities that may arise derived of it.

Well… like Murphy's law says: "Anything that can go wrong, will go wrong"…. or, maybe more appropriately: “Anything that could get worse, will get worse”.

In May, 2010, Official Journal of the European Union published the Regulation 453/2010/EC, of 20 May 2010 amending Regulation 1907/2006/EC of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

It is an amendment of Annex II to REACH Regulation, dedicated to compilation of data of SDS, to adapt it to the criteria for classification and other relevant provisions laid down in Regulation 1272/2008/EC… the new rules for classification, labelling and packing (CLP Regulation).

Regulation 453/2010 change paragraph 1.3 of annex II of REACH including an odd hue that must be taken into account. The new complete wording of it is:

1.3. Details of the supplier of the safety data sheet

The supplier, whether it is the manufacturer, importer, only representative, downstream user or distributor, shall be identified. The full address and telephone number of the supplier shall be given as well as an e-mail address for a competent person responsible for the safety data sheet.

Has the word “supplier” exactly the same scope as the concept “person responsible for placing on the market”?... there is an juridical adage that wisely says: “Whenever legislator changes a word in a law, it is changed with some reason”… if both ways of drafting lead to the same place… it was necessary to change?.

The change is not a matter of translation because it has been changed in every version of the Regulation 453/2010: it uses the word “proveedor” in Spanish, “fournisseur” in French and “Lieferant” in German.

But, sincerely, the word matters?... Let's move the words to “world of facts” and review the distribution chains we have seen before.

When producer and responsible of placing on the market are just one person, the effect is null. And in case of “re-packers with own labels” and “re-labelers”, the effect is also negligible, in both cases the word “supplier” identifies the person (I stress: legal o natural person) who provides the user with chemical products and whose data are “fully identified” in labels and SDS.

In other hand, whenever distributors provide their clients with chemical products with original labels and SDS, “supplier” and “person responsible for placing on the market” are not the same person. In many cases, direct “supplier” of many SMEs, are as well small or medium sized distributors that doesn´t have technical means to provide information or help in case of an accident or just in case of a mere doubt about the information included in the SDS.

Logic says, in this case, that our prior interpretation keeps valid and in paragraph 1.3 of an adapted SDS to CLP Regulation must be identifed the legal or natural person responsible of the information provided in the document and that may help the user in any case related to safety or environment matters on the use of the chemical product…. And that will assume liabilities as well.

But, then…. Why legislator changed the word?... does the word matter?...



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It’s time for SMGs (Small and Medium sized Governments)?

OK, you are aware. This is another boring entry with complains about how hard is to work for (and almost live on) an industrial Small and Medium sized Enterprise (SME) inside the European Union. Yes, I know, this is a recurrent topic in this blog but the closeness of end limits dates of the new European Chemicals Regulations makes clear and present a problem that very few people want to talk about.

Yesterday, as every Monday, we had our weekly programming briefing. Our Product Stewardship specialist and attorney at law, Borja Fernández-Almau reported about the project he has been dealing with for last weeks: help the last effort of one of our clients that has been working hard for five years preparing a long list of registrations on REACH Regulation with date limit on December 2010.

The main technician on Environment, Safety and Quality of this SME and Borja has been living in the factory for the last two weeks and they're planning they will have to stay there almost the weekends until December.

No, never mind, it is not the traditional “Spanish way” to leave everything to the last moments. Not at all. The European consortium has hired a very big and important consulting firm, a world class one, but every company members of it, from Czech Republic to Germany, from Denmark to Italy, is on the same dire situation.

Last week I had the chance to attend to conference imparted by Josu Jon Imaz, CEO of Petronor, the biggest oil refinery in Spain, titled “Energy and Sustainability” organized by the Official Chemical College of the Basque Country.

The conference was very interesting in deed but the debate at the end was even more fascinating. There were opinions and questions from every point of view in this polyedric matter that Sustainability is. From those who complain about the vicious circle of consume, production and environment devastation to those others who complain about the European leadership in environmental matter and the differences in regulation level among countries inside WCO, differences that, in their opinion, generate unfair competition.

Mr. Imaz answered to this last question with a very sharp and undeniable argument: we don’t have to complain about the European legislation because is a strong force to push our companies toward the innovation and, in a medium term, improve the competitiveness. He used a very old motto of AVEQ-KIMIKA: “The cleanest factory is the most competitive one”.

It was a little bit odd and very remarkable this kind of answer coming from a CEO of a very important oil company. He broke all clichés… but there is a question that kept unanswered: are there legal tools to protect the European SMEs, people who are “sleeping in the factory” to fulfill its legal commitments on time, of the external competitiveness that are free of that “strong force of innovation”?

And we are not talking about long and medium term… we are talking about next month, when the first date limit of REACH Regulation finish.

The company Borja is working with produces a chemical substance essential to the steel and aluminum industry. It is not directly used in steel factories, it is previously processed and transformed in articles (following vocabulary of REACH Regulation ).

If this SMEs sector fail in fulfilling their obligations before December 1st they will lost their permit to put on the market this strategic substance…. But, don’t worry, the European steel industry will not have to stop the production because they always can import the final articles they need from third countries… and articles are not affected by REACH… Probably, this imported articles will be low quality, environmentally worse and surely more expensive… but the production must go on.

European Union has got an strong and very detailed legislation on toys safety. The Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys and its amending acts applies to any product or material intended for use by children under 14 years old.

Is a very tough regulation that secures an harmonized high level of safety of the toys in every country of EU, symbolized with compulsory CE conformity marking in every article, that means the conformity with the provisions of these Directives.

It is not conceivable an European toys producer putting in to market any article intended to be used by children without a complete and exhaustive safety evaluation to reach the conformity assessment which permits the producer to stamp the CE marking in his products… but the CE marking is stamped by the producer himself.

Any person versed on the requirements of these Directives must go blind in a variety store … thousand of toys coming from Far East countries, every one of them marked with CE capital letters that clearly break almost every provision of the EU regulation are putting every day in to market, coming trough European customs… will be a different regime for articles that break REACH?... I don’t think so.

EU regulation signs checks that European Governments are no able to pay…. Law must be compulsory, giving to the executive branch resources to detect and punish those who break the law… if not, it will be a big load for honest professionals and a competitive advantage for dishonest buccaneers.

Big companies always has the resort to call their attorneys if they detect a competitor breaking the law… but, one of the main belief of the democracy and of the Rule of Law is that law and justice is equal for everyone and it must not depend of the money each one has…

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European policy on biocides at a crossroads

Some days ago, I read in the daily newspaper El País about the publication by the renowned magazine Science of an article about the find of dangerous mosquitoes species in Europe disappeared 60 years ago.

Written by the European correspondent for Science magazine, specializing in infectious diseases and global health, Martin Enserink (Twitter), it is focused in the recent finding of a colony of yellow fever mosquitoes, (Aedes aegypti) in the Netherlands.

As the summary of the article says, “in the latest display of mosquitoes' predilection for modern travel, entomologists have found a small colony of the tropical species Aedes aegypti—also known as the yellow fever mosquito—in the Netherlands. The insects were found on and near two facilities of a company that imports used tires and presumably originated in the hot southern part of the United States. Aedes aegypti is an important vector not just of yellow fever but also of two other viral diseases, dengue and chikunguny”

Used tires are great habitats for yellow fever mosquito because its ideal place for living are stagnant waters and used tires trend to accumulate rain water… stagnant waters in movement.

The discoverer has been the Dutch entomologist Ernst Jan Scholte who declared that although in this case Netherlands winter will terminate with them, if the mosquito spreads in the southern countries in Europe the problem will have a very different face.

In recent times, a lot has been written and published about the connection between the climate change and the spread of tropical disease in, until today, temperate climates. Nevertheless, the conquest of Europe by the mosquitoes species has no such an obvious link because the climate until half of 20th century was not in question. In fact, we are talking about a re-conquest.

Like it or not, our defense against mosquitoes, against the yellow fever or dengue, then and now, are biocides. Chemical products that defend us against the cruel nature… if someone has ever seen one of his son dying, perfectly knows what kind of cruelty I am talking about…

In my modest opinion, and in opinion of many actual experts, the European policy about Biocides, translated into Directive 98/8/EC, is unbalanced. The European Institutions have designed this policy to restrict, as far as possible, the use (and as consequence, the spread in environment and the effect on our health) of chemicals, but the point is… where exactly is the limit “as far as possible”?... are we going beyond the limit?.... I hope not to see the outbreak of a plague of yellow fever again in Europe to check it…

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What (the hell) are “bulk organic chemicals”?

There is one motto, for those who dedicate our working time to advise about industrial regulations, that European Lawmakers should take in account: a paragraph in a law is as interesting for lawyers as a "nightmaring" for technicians. And this contrast is specially intensive when the paragraph regulates the scope of the directive or regulation.

And a law paragraph is interesting when ever it has different interpretations, when two different people could understand it in different ways... a good basis for arguing that possibly ends in a process in courts. And, in my personal point of view, the industrial law maker must understand every process in courts as a fail in his performance.

We assume is not an easy task to find objective and measurable points to establish the scope of a law, to find an easy questions/answer to resolve the puzzle: "Is my company affected in this specific directive?", but we firmly think that the effort is necessary.

European Commission, and the European Court as well, use to reach a formula that industry deeply reject because it is a dangerous source of lack in equality in application of law: "A consideration on a case-by-case basis will therefore be required."

A look trough the competence crystal give us an scene where "case-by-case" analysis supposes that authorities of our competitors, any given border case sector, in Italy, Croatia or France consider that the invisible line keep our sector out of scope... But our government does not.... Our only solution is to demand the help of a judge, require a pre-judicial question to the European Court in Luxemburg and, a couple of year later and after spending a good amount of Euros, we will have a solution...

In other hand, we have objective points that give a non interpretable solution: square metres occupied, tonnes of fuel consumed, therms of gas, kWh... Avoiding any reference to “sectors” and considering any economical activity: If a company burns a tonne of fuel... does it environmentally matter if is burned in an industrial process or to keep warm a mall?

One of the last incident in such of problem is the final decision about the specific facilities included in EU ETS Directive and the scope of the sentence: "Bulk organic chemicals". Decision of regional government, competent in environmental regulation.

The Directive 2009/29/EC of 23 April 2009 amending Directive 2003/87/EC so as to improve and extend the greenhouse gas emission allowance trading scheme of the Community, in its annex I “CATEGORIES OF ACTIVITIES TO WHICH THIS DIRECTIVE APPLIES” says:

“Production of bulk organic chemicals by cracking, reforming, partial or full oxidation or by similar processes, with a production capacity exceeding 100 tonnes per day”

In this two lines we can easily find three sources of conflict: What exactly is a “bulk organic chemical”?, What are “similar processes”?.... and the only objective references (100 tonnes per day of production capacity) is inoperative by the question: Production capacity of the specific products catalogued as “bulk organic chemicals” or total production capacity of the facility?....

The Directorate-General Climate Action of the European Commission published last March 18th, a document regarding this problems: “The guidance on Interpretation of Annex I of the EU ETS Directive” but it falls again in same mistake...

Specifically, the reference to “Bulk Organic Chemicals” is this:

“Bulk organic chemicals are chemicals which are usually produced at large scale and sold as commodities for the purpose of producing other chemicals. Production processes under this activity are "cracking, reforming, partial or full oxidation" and "similar processes" (i.e. processes where severe thermal and/or oxidising conditions prevail). A production process can be assumed to be a "similar process" falling under this activity, if CO2 emissions are not only result of separate combustion of fuels, but where part of the emitted carbon stems from the feedstock. Other chemical production processes should be assessed regarding inclusion in the EU ETS under the aspect of combustion activities.

There is no exhaustive list of chemicals available that would satisfy the definition of the activity in Annex I of the EU ETS Directive. However, Table 3 can serve as a starting point. The fact that the chemicals produced are not listed in Table 3 does therefore not mean that the installation considered should not be included in the EU ETS. A consideration on a case-by-case basis will therefore be required.

In line with section 4.2, where more than one organic chemical is produced, the aggregation clause requires all production volumes to be added. Also, in line with section 3.2, the production of chemicals which have not been identified as being bulk organic chemicals and which are not individually listed in Annex I (i.e. chemicals such as ammonia, carbon black, etc) must be assessed for inclusion in the EU ETS under the assumption that the activity “combustion of fuels is relevant.”

Table 3, entitled as “Non-exhaustive list of bulk organic chemicals” includes 17 chemicals to be used as “starting point”, guide us to new unsolved questions: “Aromatics (Benzene, Toluene, Xylenes, Styrene, Ethylbenzene, Naphthalene and others)”: Which “Others”?... and in organic chemistry, only petrochemicals produce specific aromatics as a substance, but there are many other mixtures produced that include aromatics as part of the mixture.... Must we consider this mixtures as an included product?…

“A consideration on a case-by-case basis” is a heaven on earth for lawyers… industry needs that the European Union thinks almost twice before publish such kind of regulations if the true goals of European Environmental Law are avoid problems, improve Environment and unified competence in the EU and not others.



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Chemical insanities

In the Spanish version of one of the most popular social media, Facebook, there is an application called "Chemical Insanities" ("loqueras químicas"), probably developed by a Latin-American author (in Spain, people never say "loqueras", they use the word "locuras" instead).

It is just a mere jokes generator. When ever you press a key, randomly answers a "chemical joke", but the most of the jokes are very bad: "to feel more positive, loose an electron", and some other like that.

I am going to tell you another "chemical insanity", not very funny, but very, very insane: ”I once met a man who told me he understood the implementation process of GHS in the EU”. You can get crazy before...

(I personally prefer GHS - Global Harmonized System - than CLP – Classification, Labelling and Packaging… call it mania but I think is more descriptive).

We assume it is difficult. We presuppose it is complicated… but, it is possible to do it worse?. In yesterday entry, Irantzu explained her personal nightmare trying to guess what version of annex I of Directive 67/548/EEC is nowadays in force or, maybe, if the GHS Regulation came in force by the rear door.

In fact, Spanish Health Ministry is doing the reclassification of the labels of every biocide permission, adapting them, not to the GHS, what they are going to be complied to do on December 2010 (June 2015, in case of mixtures) but to the 31st Adaptation to Technical Progress of the annex I of Directive 67/548/EEC, ATP no yet implemented by Spanish Government, contributing with a little more of confusion.

Irantzu explained the doubt: GHS Regulation delay the coming into force of its own titles II, III and IV to December 1st, 2010 for chemical substances and to June, 1st 2015, for mixtures. The rest of the regulation, in January 2009.

Article 62 - Entry into force: This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Titles II, III and IV shall apply in respect of substances from 1 December 2010 and in respect of mixtures from 1 June 2015

It was logical. Industry, and authorities, needs some months of hard work to make the re-classification of every chemical, and fulfil the consequences of the new classification.

But the article dedicated to reform of Directive 67/548/EEC (Article 55 - Amendments to Directive 67/548/EEC) is on Title VII (Common and final provisions)… title that came into force on January 2009… it determinates that all references to “Annex I” included in our old and loved directive shall be replaced by “Part 3 of Annex VI to Regulation (EC) No 1272/2008” and on article 55.11 simply says: Annex I shall be deleted.

Then you may think: European Regulations do not need any transposition into internal law to be full applicable and article 55 came into force on January 2009… ergo Annex I to Directive 67/548/EEC is deleted now… ergo Part 3 of Annex VI to Regulation (EC) No 1272/2008 is fully and compulsory applicable in Spain… today!….

Well… if it were true, we should be worried about labelling, of course, but the worst part is that following the classification of chemicals came an awesome tasks of other regulations: Seveso, Safety and Health at Work, storage of chemicals… all demandable today?, all fully applicable today?... oh, my God! where’s my hole to hide myself?

But this interpretation is wrong… (thanks Lord!), because in this case Regulation 1272/2008 is a mere instrument to reform the Directive 67/548/EEC but the nature of the Directive does not change it, in its new redaction, still needs a transposition to internal law.

If not, if GHS came into force on January 2009 (by the indirect gate of eliminate de annex I to Directive 67/548/EEC)… would had any sense to publish two additional directives of ATPs (30th and 31st)?, in fact: would had any sense to delay the application of any part of GHS if the key stone is compulsory nowadays?

More absurd would be to understand that ATPs 30th and 31st are applicable without implementation of a Royal Decree or Ministerial Order… which is the magical difference between the last two ATPs and the 29 prior ones?

As we have been doing for years the recommendation of accomplish the European Directives as soon as possible, we advise not to wait the implementation. Because moral responsibility and, also, by legal responsibilities….

Our recommendation of adapt our classification, labelling and MSDS to the 31st ATPs is on the table…. And start working jointly with GHS too. But, we must have clear that one thing is a recommendation and other, very different, is an obligation, a legal obligation.

We have hard work until December 2010, but permit us do it… please.



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