How to prepare an Annex XV report

You may want to use the information sources listed below when you prepare the restriction proposal. They are structured according to the headings of the template in the Annex XV format. Some of the links might not be relevant for all the cases and other information sources might be needed to prepare the restriction proposal.

How to prepare an Annex XV report

Problem identified

Previous assessment and opinions
- Risk assessment reports under previous legislation (ESR)
- Annex XV transitional reports and voluntary risk assessment reports
- PBT/vPvB assessments under the previous EU chemicals legislation
- SCHER opinions
- OELs
- Reference documents under the IPPC Directive and the IED
- OECD information
  (Directories and databases for chemicals and biosafety)
- IARC information
  (Monographs on the Evaluation of Carcinogenic Risks to Humans)
- WHO information
  (Environmental Health Criteria documents)
- USA/ATSDR
  (Toxicological profiles of substances)
- Australia/NICNAS (Assessments of chemicals)
Databases
- Information on Chemicals;Search for Chemicals"
  (C&L inventory, SiA notifications, public information from registrations etc.)
- Information toolkit > eChemPortal
  (Global portal to information on chemical substances)
- IPCheM
- SPIN
- RAPEX notifications
- Eurostat
  (Statistics at European level)
- Eurostat/Prodcom
  (Statistics on the production of manufactured goods)
- EIONET
  (Information concerning Europe’s environment)
- E-PRTR
  (Key environmental data from industrial facilities)
- NORMAN - EMPODAT
  (Network of reference laboratories, research centres and related organisations for monitoring of emerging environmental substances)
- DEMOCOPHES
  (Demonstration of a study to coordinate and perform human biomonitoring on a European scale)
- MADB
  (Import conditions in third country markets)
Other legislation
- Technical assistance related to the scope of REACH and other relevant EU legislation to assess overlaps
  (Thematic studies for review of REACH 2012. Provides information on EU legislation)
- EU-OSHA
- EFSA
- EEA
- Poison centres in EU and outside EU

Alternatives

ECHA Substitution Website
SUBSPORT
(Alternative substances and technologies, as well as tools and guidance for substance evaluation and substitution management)

Impact assessment

ECHA SEA web pages
Willingness to pay to avoid certain health impacts
(Stated-preference study to examine the economic value of benefits of avoiding selected adverse human health outcomes due to exposure to chemicals)
Abatement costs of chemicals – workshop information
Estimating the abatement costs of hazardous substances
(A review of the results of six case studies)
Substitution Toolbox
(The OECD substitution and alternatives assessment toolbox (SAAT))
EU Impact assessment guideline
(Guidelines for Commission staff preparing impact assessments)

Assumptions, uncertainties and sensitivities

Guidance on information requirements and chemical safety assessment Chapter R.19: Uncertainty analysis [PDF]