Interview - Guido Sacconi MEP on REACH

In an interview with EURACTIV, the Parliament’s lead Rapporteur on the REACH proposal, Guido Sacconi, said he is considering restricted opt-out solutions for companies when vital business interests are at stake.

Click here to read the shorter version of this interview

In its proposals to make REACH more ‚workable‘ for companies, the European chemical industry council (CEFIC) is supporting an approach whereby chemicals would be registered based on the risks they might pose to health or the environment rather than on the volumes produced or imported. You support the volume-based approach of the Commission’s initial proposal. Why do you think this system is better? 

At first sight, it would indeed seem that industry’s proposal on the risk-based approach is one of common sense – it is right to say that the most dangerous substances should be registered first. 

But I have two comments to make on this. First, the Commission’s initial proposal is already based on risk. In the first group of substances (that enter the system within the first three years), there are not only substances produced in great tonnage but also those that are carcinogenic, mutagenic or toxic for reproduction (CMR). My first amendment would be to add the PBT and vPvBs [persistent, bioaccumulative and toxic substances and very persistent, very bioaccumulative substances] to this group. So, this is where the priority lies!

Without taking account of the volumes?

Yes, this is the first thing. The second thing is that, up till now, we have not found an alternative system to the one proposed by the Commission that gives an equivalent degree of legal certainty and which does not reduce the scope of the regulation. The Commission proposal of October 2003 is the conclusion of a process and a compromise within the Commission, which has decided to concentrate on 30,000 substances out of the 100,000 substances which are not yet known!

I am open to suggestions, but all the ones that I have seen from industry so far argue for more flexibility in the quantity and quality of information which companies have to submit to the agency. They either call for less substance or less information, so I remain convinced that the proposal is better as it is now.

In July, I said a compromise solution could be found and that we could start with the Commission system with high tonnage (EURACTIV, 18 July 2005). Halfway through, we could find solutions for small tonnage on the basis of a proposal that would be technically guaranteed by the agency. 

You have strongly criticised the European chemical industry confederation (CEFIC) for putting forward SME’s competitiveness concerns as the main remaining stumbling block with REACH. Why is this?

My criticism of CEFIC or UNICE [the European employers‘ confederation] was not that they underlined SMEs‘ concerns. As I have said, I come from a region in Tuscany where 95% of companies have less than 10 workers so I have a good understanding of small enterprises. A lot actually come from the chemical sector or are downstream users of chemicals – textile, leather, etc. 

What I am saying, is that it is not true that they represent the interests of small and medium-sized companies. Their line is to reduce the amount of information required for large tonnage. If it is true that small tonnage does not necessarily equate to small companies, it is clear that large tonnage does equate to large companies. And a lot of these companies are not European but American.

As far as I know, CEFIC is not there to defend the interests of the US industry…  

Because CEFIC has not already officially said yes to the OSOR [One Substance, One Registration] proposal on which all political groups have already found a compromise – a proposal which allows sharing data and costs in particular with SMEs. Why has CEFIC not said yes to this proposal yet?

On the OSOR proposal, CEFIC wants to ensure that companies enter consortia on a voluntary basis to protect their intellectual property. 
Is this not a legitimate concern to you?

This is a legitimate concern but we have already defined amendments which address this aspect, including an option to opt out from consortia. 

Then, you seem to agree with their proposal, which says an opt-out from consortia should be allowed when vital business interests are at stake. Is this a reasonable option according to you?

This is reasonable and this is why we have tried to find solutions to guarantee this. But what CEFIC has probably not yet understood is that by the time they will be ready to accept this in principle, a first reading will have taken place in Parliament and – in all probability – the Council will have already defined its political agreement…

What are your proposals to guarantee the continued protection of intellectual property? Is the opt-out the only solution you are putting forward?

Solutions are being defined in other Parliament committees such as industry (ITRE) and internal market (IMCO).

Will you take their amendments on board?

Yes because the environment committee is the last to vote but the one which takes the report to the plenary. Before the plenary vote, we will try to build up the most intelligent mix possible.  

Can you briefly explain the philosophy of the amendments which you plan to take on board from other Parliament committees?

To improve REACH and make the system more manageable for SMEs (OSOR); strengthening the role and of the institutional model of the agency for an increased centralisation of the evaluation procedure of substances in order to avoid distortions in the internal market.

On intellectual property protection, the agency will have a key role, it will decide whether data should be shared or not.

What would be your proposed system? Could the agency force a company to share data?

A real obligation? Maybe. But there would be strong incentives to do so because of cost sharing. On this topic, the Council has worked a lot. What we have introduced is this possibility of opting out for companies which can really prove to the agency that some data or data package on a given substance is truly decisive for its competitiveness. Then it would have the possibility to opt out from the consortia. And then the agency would grant the opt-out authorisation or not.

One of your proposals is also to make some data available to SMEs free of charge 10 years after they are registered at the agency during the first three-year registration phase. Is that right?

I have not yet tabled amendments in that direction. They are just some points of exploration to see if a compromise is possible also on the registration issue. What I have proposed is to prolong for two years the timing for the registration of the smallest volume band. The Commission proposes 11 years to register substances in the 1-100 tonne range. What I propose is to create an extra 1-10 ton range, for which registration could take 13 years (2 years extra). This solution renders effective one of the requirements of the Commission proposal according to which data on a substance registered 10 years before is free for newcomers. Bear in mind that this fourth 1-10 tonne range concerns 20,000 substances out of the 30,000 covered by the regulation!

Would this give enough time for industry to recover their R&D costs? In other words, would this preserve industry’s innovation capacity?

From the cost perspective, yes of course. And especially for SMEs because they do not yet have access to the data held by large companies for the large volume substances. Large companies who produce the large volume substances already have the data in their possession. But they do not want to share it!

So, you are favourable to a mandatory sharing of data in a consortium?

I foresee the possibility that a small volume producer (therefore likely to be an SME) is allowed to enter a consortium from the very first moment. When a consortium is formed, instead of entering ten years after (which could mean 13 years in total), they would be allowed to enter before. Imagine: if the regulation enters into force in 2007, we’re talking about 2020!

Would this mean a mandatory sharing of data for large volumes? 

No, it would be the same for all volumes. 

On the political side, do you expect a confrontation with the Parliament rapporteur for the internal market committee, Mr Nassauer (EPP, Germany)? How do you plan to manage the relation with the EPP in Parliament when it comes to the vote?

Mr Nassauer, Ms Ek [rapporteur for the trade and industry committee] and myself have a common conviction that it is absolutely necessary to build a large majority in Parliament on this dossier. The permanent contacts we keep with the Council and the Commission allows us to avoid conflicts on the principles. There will be differences in opinion in the details but on important points such as OSOR, there is a convergence of views. 

Still, we need a large majority. Currently, and especially because of the registration issue (risk-based or not), there is no large majority. 

The risk-based approach is defended by Mr Nassauer in the internal market committee and he might well get the support of his group in plenary. The EPP is the largest group in parliament, so this is a fundamental difference of opinion!

Maybe Mr Nassauer will win the vote in his committee and I will win in mine. But all three of us [Sacconi, Ek and Nassauer] know that we may need to seek a compromise right up to the last moment – ahead of the vote in plenary. There is a Maltese-Slovenian proposal that we are currently working on…

What is your opinion on this Maltese-Slovenian proposal? It has been harshly criticised by environmentalists for being inspired by the risk-based approach.

I have a lot of critical comments to make on this proposal. I consider it as a variation of the risk-based approach but there is a very important political point: If this proposal is used as a basis for compromise, it means it has to be respected. As it is, the proposal would grant special treatment for small volumes and only for small volumes. If it is used for all volumes, I do not agree. This would be like adopting an entirely risk-based approach. 

But it could also be a point of departure to find a compromise that would include special treatment for small volumes, an extra two-year delay for registration [for small volumes], and maybe also a nuance in the data that needs to be submitted to the agency [for small volumes]. We will see…

But let me restate the main political aim of REACH. Registration is the means but substitution of the most dangerous substances – whenever feasible and when it is safer – is the aim. We have to push for the competitiveness of the European chemical industry with improved quality products on which consumers can rely with confidence.