Chemical Watch reports that Echa says changes to the REACH dossier technical completeness check (TCC) – its main tool for implementing REACH’s 'no data, no market' principle – will make it is easier for it to revoke registration numbers.
The agency plans to publish an information package on the changes and their impact, by the end of the year.
In some cases, the agency will conduct a manual examination of dossiers as part of the changes to the TCC process (CW 22 April 2015).
The "no data, no market" provisions of REACH are pursued in the registration process and the compliance check. Echa's Doris Thiemann says the agency is planning to enforce TCC by checking if all necessary information are included in the registration dossier. She says: “We expect this to be a major way forward to improve the quality of registration dossiers and to enforce ‘no data, no market’.”
Until now, the TCC process has been automated, allowing dossiers containing data of questionable quality to receive registration numbers. NGOs say such dossiers flout REACH’s 'no data, no market' principle (CW 16 January 2014).
They also say it is difficult to trace how member states respond to evaluation decisions, which come at the end of the dossier compliance check process. These are issued by Echa for dossiers deemed to be non-compliant. So far, registrants have updated dossiers in response to over 600 such decisions.
When following up a registrant’s actions in response to them, Echa may decide that the dossier is still non-compliant and issue a statement of non-compliance (Sonc), inviting national enforcement authorities (NEAs) to take action.
Echa says the number of cases provided to NEAs is “steadily growing” and the process works well because the latter's actions “result in information requested in the decisions being submitted to Echa”.
According to Echa’s 2014 evaluation progress report, 72% of registrants complied with evaluation decisions before a Sonc was issued; 11% complied after receiving a Sonc; and in 1% of cases a new compliance check has been started. The remaining 16% are still in progress.
So far, Echa has released 46 Soncs to Chemical Watch following access to document requests. The latest batch includes 23 registrations.
There is no deadline in REACH by which Echa should check registrants have responded to an evaluation decision, but it aims to perform the follow-up within six months of the deadline set within it, for at least 75% of the cases.
The agency says the process can be “laborious”, especially in cases where “adaptation of the standard information requirements has been done”.
It typically takes about ten months, from when a Sonc is issued, for the registrant to comply. So far, the agency has not come across a case where revocation of a registration number was deemed necessary.
According to the information released toChemical Watch, some evaluation decisions refer to multiple data gaps in the dossier. However, Echa would not confirm whether these might be so-called 'google dossiers' and said the evaluation process does not categorise cases, based on the level of information included.
The update to the TCC process aims to identify dossiers containing information that is inconsistent with the Iuclid data field.
At the most recent Echa Management Board meeting, the European Commission confirmed that the changes to the TCC process are within the scope of the completeness check, and can apply to updates “as long it is reasonable and necessary”.
It also said Echa may invalidate registration numbers in well-justified cases.
Many board members welcomed this step as major way forward to improve the quality of dossiers.
At present, Echa says it only withdraws registration numbers in exceptional cases or after the TCC process. So far, revocation has been considered in cases where registration numbers were assigned to registrants found to be non-existent, and where they failed to pay the correct registration fee.
Erwin Annys, Cefic REACH director, said it is difficult to predict the impact of the revised TCC process.
He says: “A manual check of all dossiers does not seem to be realistic. Everything will depend on which dossiers will be manually verified. And this creates quite some commotion within industry, not knowing what will happen if a registration number is not obtained in time.”