REACH and SDS RequirementsPresented by Paula Laux

Senior Regulatory SpecialistWercs Professional Services

REACH and SDS Basics

• Regulation considers the SDS as key hazard and risk communication element

• Legal requirements based on adaptation of Globally Harmonized System for the Classification and Labeling of Dangerous Chemicals (GHS)

• Legal requirements may need further adaptation to comply after GHS is implemented

REACH and SDS Basics

• REACH regulation replaces the current SDS Directive (91/144/EEC)

• Current Responsibilities/duties for SDS remain, but are also extended.

• Nationally (each country in EU) will need separate national transposition of the SDS regulations which could lead to differences among member countries

• REACH will not have member state specific implementations

REACH and SDS Requirements

• Where a substance meets the criteria for classification as dangerous in accordance with Directives 67/548/EEC or 1999/45/EC, an SDS is needed

• If a Chemical Safety Assessment is part of the registration requirements, the SDS must be consistent with the assessment

REACH and SDS Requirements

• If the preparation does NOT meet criteria for a classification as dangerous, but > 1% by weight for non-gaseous preparation and > 0.2% by volume for gaseous preparation of at least one substance posing a health hazard, an SDS is needed

• If the preparation does NOT meet criteria for a classification as dangerous, but > 1% by weight for non-gaseous preparation and > 0.2% by volume for gaseous preparation of at least one substance for which there is a community workplace OEL, an SDS is needed

• If the downstream user requests an SDS.

REACH and duty to Communicate Information

• All substances placed on market regardless of hazard will require downstream “Hazard Communication document”

• The format and contents of the document will vary depending on whether the substance is meeting criteria for classification as dangerous and/or registered

REACH-Duty of Downstream User (DU)

• DU required to play active role in providing information up the supply chain on intrinsic properties.

• New information on hazardous properties

• Information that might call into question appropriateness of the risk management measures on the SDS.

REACH SDS Requirements

Now that REACH is enacted there are different content SDS requirements for substance placed on market which meet criteria for classification as dangerous.

REACH and categories needing various SDS Requirements• SDS for substance out of scope of REACH

(Article 2) or substances registered under REACH (S< 1 t/y)

• SDS for substance subject to Registration requirements, but for which a CSA/CSR is not required (1-10 t/y)

• SDS for substances in the scope of REACH and subject to CSA/CSR

Best Source of Detailed Information

Google: REACH in BRIEF

http://ec.europa.eu/enterprise/reach/docs/reach/reach_in_brief_council_comm

When do you need an Extended SDS

• For Substances meeting criteria for classification as dangerous or PBT/vPvB substances manufactured or imported at >10 t/yr which are placed on market

• For Substances >100 t/y where testing proposal from technical dossier has been approved by competent authority and testing was completed-- additional information will need to be incorporated into relevant sections of SDS

• For phase in substances the timescale by when the extSDS will be needed will be dependent on the deadlines for registrations governed by tonnages and classification

Responsibilities for ExtSDS

• Person at M/I or DU level responsible for adding additional information—if a CSR and extSDS is required

• ExtSDS must deliver information to DU in a form which allow him to check that his intended use/controls are in a form provided by upstream suppliers

• DU must consider if the Risk Management Measures on extSDS are relevant to his conditions of use

• DU must pass on relevant information to customer down supply chain

Extended SDS Requirements

• Specification of identified uses

• Derived No-Effect Level (DNEL)

• Predicted No-Effect Concentration (PNEC)

• Exposure Scenario

• Related Risk Management Measure

• Information on related waste disposal

Questions?