ORO Facts & Figures 2018:
Current number ORO Member 34 (2018)
- 33 ORO Full Members located in 11 member states:
- Germany (8) / UK (7) / Netherlands (4) / France (3) / Belgium (3) /
Spain (2) / Finland (2) / Bulgaria (1) / Ireland (1) / Italy (1) / Luxemburg (1)
- 1 Associated Member located in Turkey.
ORO Member Impact:
- ORO Member represent 2.461 Non EU Manufacturers (NCM) worldwide,
the majority (1.829 NCM) are located in Asia
- ORO Members cover 4.500 REACH registered substances until Dec. 2016
- ORO Members cover 19.712 Importing Downstream User - for 25.328 individual substance imports.
- 57 Acting in Pre-SIEF as SIEF Formation Facilitator
- 98 OR registrations made as Lead Registrant (LR)
- 225 ORO members involved in consortia
REACH - Enforce-3 Inspections
- ORO Members have inspected since 2008
- In 2014 (REF-3) 20 out of 29 ORO Members have been inspected.
Identified issues REF-3:
- Validity of OR Assignment and appointed substances
- OR / Importer capability of Substance Volume Tracking (SVT) and identification of importing DU
- Safety Data Sheet obligation
- Other individual issues in focus of regional inspectors (e.g. chemical expertise check, documentation obligation Art. 36, etc.)
ORO was very concerned to learn on the high number of OR Non-Compliance published in the ECHA REF-3 results.
Still, ORO Members passed well in REF-3 inspections.
In general there were no major findings among inspected ORO Members.
Main issue between OR and inspectors was the obligation on SDS.
Since ORO Members are Regulatory Service Providers who are not placing the appointed substance(s) on the market, the majority inspectors acknowledged, that ORO Members in general act according to the ORO BestPracticeGuide and the ORO PositionPaper on SDS.
Only in one single case, a regional inspector refused to follow the ORO argumentation on SDS and issued a failure report on one Member, while other inspectors in the same Member State accepted the argumentation under the precondition that the OR is NOT responsible for placing on the market.
Since the one ORO Member in focus is not placing any substance on the market, and acts according to ORO Best Practice, the ORO Association supports this member and can not see any issue of non-compliance in this case.
Feedback on Inspections
ORO has always welcomed inspections on OR´s and since 2008, many ORO Members had been inspected already.
Therefor ORO has supported inspection activities in the past and welcomed the REF-3 Inspection on importers and OR´s.
Inspected ORO Members reported that under REF-3, OR Certificates presented by Importers where exchanged among Member State Authorities and triggered OR Inspection in another Member State, in order to verify the reported OR Volume coverage by the importing Downstream User.
This reported joint Member State action under the REF-3 initiative showed, that the quality and knowlege on OR related issues has significantly risen in REF-3.
Still, there is room for improvement, especially on an individual staff level in a few Member States. In some cases ORO Members reported that inspectors had a lack of knowledge on OR obligations. In some cases, Inspectors were not aware that ORO AISBL (ECHA Stakeholder) existed and therefore had no knowledge on ORO publications such as the ORO Best Practice Guide, that can also be found as reference on the ECHA Web Page.
More concerning was the fact that in some Member States, individual interpretation on OR obligations exist on a personal (inspector) level. Depending on the location of the OR in a Member State, the same issue may be evaluated differently.
This location related individual REACH interpretation on obligation can lead to NO to very DRASTIC (legal) consequences, as described above (eg. collecting and providing information, SDS).
Overall and despite the room for improvement on all sides, ORO considers the REF-3 inspection on Importers and Only Representatives a success for ECHA, the Member State Authorities and ORO Members.
The high number of OR´s identified as non-compliant are kindly invited to become an ORO Member, or at least follow the ORO Best Practice Guide. Importers should consider the ORO Information Document on REACH Compliant Imports.