From time to time, you may disagree with your substance classification. You want the classification to be re-looked at.
The EU system is very accommodating. It is designed for these eventualities. After all, given the inherent problem of knowledge, vital information may have been overlooked during the classification.
Officials are loath to second guess scientific experts. They are less keen to second guess the opinions of a regulatory agency set up to give advice on the science. And, when it comes to a chemical, nearly all officials will not try and second guess the science. The aversion amongst politicians to second guess regulatory science is even higher.
This aversion gene is not present in French politicians. They are happy to second guess and over-rule ECHA or EFSA when they don’t agree.
REACH provides a useful mechanism in Article 77(3)(c). The option has been used 17 times to look at SHVC identification, toys, OELs, and re-looking at classifications. In re-looking at classifications, it’s been used four times for two substances.
Reasons
The reasons for re-opening are similar. They are about the consideration of relevant and new scientific information. The Commission has raised the following reasons:
- see whether any new of relevant studies
- evaluate the information on toxicity to reproduction submitted during the public consultation on carcinogenicity and take into account also information submitted by Eurometaux in December 2011
- No Qualified Majority Vote in REACH Committee because “study reports had not been available and could not be taken into account by RAC at that time
Observations
In the four cases, the Commission asked ECHA to re-open.
In all the cases, the RAC re-confirmed their existing position.
These re-opening cases happened several years ago. Reading the minutes of the Regulatory Committees, there is a clear reluctance to admit ‘new’ science after decisions have been taken. It’s seen as an ill-disguised ploy to drag out the decision making process.
It is hard to imagine that relevant new scientific evidence will come to light that would lead to the RAC to change their opinion. But, it is not impossible. It is clear from these cases, that vital and relevant scientific evidence may come to light, even after the RAC has come to an opinion, that leads the Commission to ask ECHA to re-open the opinion. It is clear that this ‘new science’ will have to be convincing to get the Commission to move and even more so to get the RAC to come to a new opinion.
If the Commission is not persuaded, the option exists for a Member State to launch a new classification based on the new science.
Case 1: Substance: Epoxiconazole toxicity to reproduction
17 March 2010: First RAC Opinion (link)
10 December: Request from Commission to ECHA (link)
17 January 2011: Mandate from ECHA Executive Director to RAC (link)
11 March 2011: RAC Opinion (link). Re-confirms opinion.
23 February 2012: No Qualified Majority Vote in REACH Committee
Reason: The absence of a qualified majority was due to a number of additional studies that have recently been made available by industry to the Commission. Several of these studies had been noted already by RAC when it adopted its first opinion, but the study reports had not been available and could not be taken into account by RAC at that time.”
25 April 2012: Mandate from ECHA Executive Director to Chair of RAC.
28 November 2012: RAC Opinion. Re-confirms opinion.
2 October 2013: included in 5th ATP (link)
Case 2: Substance: Gallium arsenide in relation to Carcinogenicity
25 May 2010: First RAC Opinion (link)
10 December 2010: Request from European Commission to ECHA (link)
18 February 2011: Mandate from ECHA Executive Director to RAC (link).
Reason: to “see whether any new of relevant studies.”
1 December 2011: RAC Opinion. Re-confirms opinion (link).
2 October 2013: included in 5th ATP (link)
Case 3: Epoxiconazole
17 March 2010: First RAC Opinion (link)
10 December 2010: Request from European Commission to ECHA (link)
17 January 2011: Mandate from ECHA Executive Director to RAC
Reason: “whether it is possible that the results of the planned, currently ongoing or planned studies that have been discussed with Regulatory authorities under the regulatory evaluation and approval regime … could be relevant for deciding on the appropriate classification of the substance …”
11 March 2011: RAC Opinion. Re-confirms opinion (link).
2 October 2013: included in 5th ATP (link)
Case 4: Substance: Gallium arsenide in relation to toxicity to reproduction
25 May 2010: First RAC Opinion (link)
Undated: Request from the European Commission to ECHA
21 December 2011(revised 17 April 2012): Mandate from ECHA Executive Director to RAC (link)(link).
Reason(s): “ verify whether the information submitted with regard to toxicity to reproduction contains elements relevant for classification purposes that were not already examined by RAC when it adopted its opinion of 25 May 2010” and “On 23 December 2011, Eurometaux submitted additional information highlighting that the data were not submitted during the public consultation in 2011 as it was limited to carcinogenicity:
23 July 2013: RAC Opinion. Re-confirms opinion (link).
Reference
ECHA website (link)
Note: ECHA Framework for Dealing with Requests for opinions according to Article 77(3)(c) of the REACH Regulation (link)