Implementation of REACH (debate) 
President
The next item is the oral question to the Commission on the pre-registration of phase-in substances according to the REACH Regulation - (B6-0490/2008).
Guido Sacconi
author. - (IT) Madam President, ladies and gentlemen, I will not take up a great deal of your time because this is a well-known topic. We are talking about the pre-registration of chemical substances, a preliminary stage, in fact the first stage in implementing REACH, which is very important. This is because it offers companies the opportunity to establish the right to apply a transitional regime, in other words, stagger the times specified for registering substances. This is a more demanding procedure which above all, even more importantly, can lead to the formation of groups of companies for sharing data. This means that data can be presented jointly by producers of the same substance.
As we are all well aware, we have received information to the effect that, compared to the initial forecasts which the REACH system was based on, the number of pre-registrations has not only been high, but actually far higher than predicted. We were talking in terms of a few hundred thousand, but the number of substances which have been pre-registered, and the Commissioner will certainly give us the exact figures for this, has probably passed the million mark. This presents a problem for us as it also raises a lot of questions about the causes of this explosion, or phenomenon you might say, which could even be positive. The main thing we know is that this avalanche of data, though still preliminary basic information, has severely tested the ability of the newly formed European Chemicals Agency in Helsinki to handle it.
Our question then is exactly this: we want to know how these problems were tackled, what kind of structure has been set up if problems have been caused for the companies who have been very anxious, for want of a better term, about being able to meet the deadline. The deadline for submitting these pre-registrations expired at 12 midnight on 1 December. We also want to know what are the Commission's analysis and initial assessment of this phenomenon and what problems it may well cause during the next phase of implementing this regulation.
John Bowis
author. - Madam President, like Guido Sacconi I can be fairly concise about this. This was perhaps the biggest dossier that this Parliament has known in recent years. It is one of the biggest operations on which it has embarked, and is of crucial importance in terms of the health and safety of people as they handle, use and consume chemicals which may be hazardous, dangerous or risky and so require great care.
That is why we set up REACH. That is why we brought in the pre-registration process and, subsequently, the authorisation process. That is why we are concerned to hear that it has snowballed in such a way as to almost suffocate this newborn agency.
Guido Sacconi said that he was not sure about the number of pre-registrations, but he thought that they were over one million. I can tell you that, on 1 December, when the process closed, that figure was over 2 million. It was 2 212 129 registrations from 65 655 companies. That is the scale of what has happened.
The question is: why so many? The answer, I suspect, is because a lot of firms were advised to take precautionary measures in case they had to go through the much more expensive processes later.
But the question then is: in September when we were first alerted to this, was the Commission able to step in to give support? Does the Commission believe that the registration process will now be adequate, and what steps will it take to make sure that the rest of this Agency's processes work smoothly and effectively?
Günter Verheugen
Vice-President of the Commission. - (DE) Madam President, ladies and gentlemen, I should like to thank Mr Sacconi and the other authors because their question gives me the opportunity to report to the European Parliament on the indeed astounding results of the pre-registration procedure within the framework of REACH. Pre-registration of the chemical substances available on the EU market is the first procedure within the framework of REACH. It represents the precondition for extended registration periods for companies, which then extend to 2018.
The pre-registration period stipulated in the REACH Regulation began on 1 June 2008 and ended on 1 December 2008, in other words six months later. In adopting the regulation we had assumed that we would have to reckon on the registration of approximately 200 000 chemical substances. In actual fact, by the end of the pre-registration period there had been precisely 2 236 625 registrations. Several thousand collective applications are currently still being processed and may still increase this figure considerably.
The final figure will be made known by the agency in mid-December. Naturally, we too asked how it was possible that the estimates which formed the basis of our legislation had been exceeded tenfold. The simple answer is for precisely the reason that REACH was developed: because we simply did not know - because no one knew precisely - how many substances we had available.
It has emerged that the extent of the task was underestimated by all those concerned. The estimates were made with the aid of all available data from the Member States and industry. Naturally, they initially resulted in problems occurring when it turned out that the working hypothesis had been wrong. That was quite inevitable. According to the REACH Regulation, it was the task of the agency in Helsinki to establish the format for pre-registration and to make it freely available on its website. The REACH IT system and the corresponding format for pre-registration of the substances concerned was available to companies on time on 1 June of this year.
In the course of October and November companies informed the Commission that the REACH IT system operated by the agency was working with reduced performance or at certain times not at all.
The Commission subsequently monitored the agency's operations very carefully and discussed improvements to the software and even an emergency plan with the agency. Throughout the entire pre-registration period, the agency worked hard to improve the performance and efficiency of the IT system. In view of the rapid increase in pre-registration figures in recent weeks - up to 100 000 pre-registrations on a single day at times - the agency has taken additional technical measures and expanded its capacity.
These changes made it possible to improve the availability and speed of the system. Nonetheless, at peak access times a delayed response could not be completely avoided because of the extremely high number of simultaneous requests. It really is the case - and a few questions can be linked to this - that almost half of all the pre-registration applications were submitted in the last two weeks of the pre-registration period, that is to say, more than one million in the last two weeks.
For this reason the agency recommended performing pre-registration outside peak times in the event of difficulties. In addition, companies were advised to use the format for collective registration, which was the fastest option. In the last phase of pre-registration the agency set up an additional, rapid telephone answering service for help with any problems. Due to this measure, the response time in the REACH IT system constantly improved despite the high number of pre-registration applications.
Finally, the prepared alternative procedure was only used on the very last pre-registration day and only proved necessary to a limited extent as the REACH IT system operated adequately until the last after all. I am assuming that, despite the difficulties which occurred, all the companies concerned were in a position to pre-register their substances and that the first implementation phase of REACH was thus successfully concluded.
Carl Schlyter
on behalf of the Verts/ALE Group. - (SV) Madam President, I want to thank the Commissioner for his answer. In view of the fact that the number wanting to pre-register was so incredibly higher than we had first thought, I think we can still say that a lot has worked. After all, despite everything 2.2 million people have succeeded in registering - and from 65 000 different businesses, as Mr Bowis said. No doubt it is actually a good thing that we are made aware of how much the chemicals are used. Perhaps it indicates a certain nervousness and a feeling of 'better safe than sorry' which is resulting in people registering even though the same use may already have been registered, et cetera. However, we will not be able to tell whether this is the case until later.
As a result, however, I wish to ask a follow-up question. In sharp contrast to the number that have pre-registered their chemicals, we have extremely few chemicals on the candidate list of the most dangerous chemicals. There are just 15 at present, when we have 27 PBTs and 800 other chemicals that should already be included here. Imagine if there were to be a very rapid increase in these. In future proceedings within REACH and as we approach the next deadline, how will the European Chemicals Agency cope when decisions are required from it? In my judgment, we need to increase the workforce of the European Chemicals Agency substantially if REACH is to succeed. Otherwise I believe that at the end of the next stage, when we need decisions from the Agency, they will have no chance of making the required decisions in time. I therefore really believe that we must make provision at this stage for a substantially increased budget for the European Chemicals Agency.
Guido Sacconi
author. - (IT) Madam President, I would first of all like to thank the Commissioner because I found that the answers he gave were very persuasive. I understand in particular that this explosion of pre-registrations obviously reflects an important aspect of this matter, as he himself said. We have had problems because REACH has even been operating too efficiently and has uncovered substances that are actually unknown, which are starting to pop up.
I would like to ask a question, if I may, which is perhaps premature as it is not possible yet to probably have the relevant data and an assessment of this matter. After all, we always thought that the system would more or less include somewhere around 30 000 substances. In light of the number of pre-registrations, are you able right now or in the near future to quantify the number of substances which will be entered in the system via pre-registration? The reason for this question is because faced with a significant increase in this number at the moment, this should obviously make us think about how subsequent phases are going to operate.
Günter Verheugen
Vice-President of the Commission. - (DE) Madam President, I cannot answer the question as to why this enormous difference has come about between the estimates and the actual result. I am neither a scientist nor an administrative officer. Like you all, I also relied on these estimates being reasonably accurate. However, I am not blaming anyone, because it was in fact the case that this could not be known accurately. Had we known precisely which substances we deal with daily, REACH would not have been necessary: It is precisely because we did not know this that we needed REACH.
In this respect, this initial result that we are discussing today is very convincing proof that it was necessary to set this project in motion - I see that Mr Sacconi is nodding - it is shining proof that this legislation, very heavily criticised in public, was indeed necessary after all.
This initial phase is not about expanding the list of hazardous substances. This phase is also not about authorising something or other. The initial phase is firstly about knowing what is actually out there, and thus giving companies the opportunity to avail themselves of those manufacturers who have pre-registered the substances when obtaining their supply of those substances. The system will, as envisaged in the regulation, develop gradually, and in the course of this process the list of hazardous substances will probably grow longer.
Naturally, there is the question of which problems will arise for industry with continued use of REACH. We will examine this very closely based on analysis of the pre-registrations received. However, at present it cannot yet be said what exactly this large number really tells us. We need a bit more time for that and I would suggest that I come back either to this House or to the committee to inform you of the result of the analysis and also give you a precise report on the next steps.
President
The debate is closed.
