REACH Compliant SDSs: What’s - British Cleaning Councilbritishcleaningcouncil.org/wp-content/uploads/2016/07/Lisam-SDS... · • Acquisitions: ESI Protheus, Telegis, etc ... Detergents

© LISAM SYSTEMS 2016

Simon Bradshaw, June2016

REACH Compliant SDSs:What’s Changed and What’s Coming


REACH Compliant SDSs:Structure, Content and Requirements



• REACH ...

• Regulation 1907/2006

• Amendment 453/2010

• Amendment 2015/830

• Classifications … GHS

• 12th ATP to CLP alignment to GHS

rev 6

• 11th ATP translation of substance

names. Vote Oct 2016

• 10th ATP adding / amending

harmonised substance

classifications. Vote Sept 2016

• 9th ATP (47 substances). Adoption

2Q2016

• 8th ATP aligns CLP with 5th Ed UN

GHS). Applies from 1 Jan 2017

• 7th ATP (35 substances)

Applies from 1 Jan 2017


COMMISSION REGULATION (EU) 2015/830 of 28 May 2015

amending Regulation (EC) No 1907/2006 of the European Parliament and

of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)


• Different EU MS require own

language(s)

• Some EU MS often have

individual specific requirements

• Some key SDS structure

changes:

Email

Emergency tel nr

Section 9 incl pH and

concentration (aq.)

Sections 2 & 3 reversed

ES for substances

• SDS continuously updated

through the life cycle of the

product and SDS kept 10 years

after last supply









Requirements for the safety data sheet (SDS) are laid down in Annex II to REACH.

Two conflicting amendments of Annex II were due to come into force simultaneously

on 1 June 2015, one made by Article 59(5) of the CLP Regulation and the other by

Commission Regulation (EU) No 453/2010. Therefore Commission Regulation (EU)

2015/830 was published to clarify these amendments. In addition, a number of small

changes recently adopted into the GHS are also reflected into the new regulation.

The measures took effect on 1 June 2015; however, recipients who received a SDS

before 1 June may continue to use it until 31 May 2017, or until a mandated update is

required.

From 1 June 2017, ALL SDS must be in compliance with the Annex to Regulation

(EU) 2015/830, and ALL substances and mixtures must be classified, packaged and

labelled in accordance with the CLP Regulation, 1272/2008, even those already in the

supply chain.

http://www.reachready.co.uk/CLP.php





Substance name in product identifier in SDS

Order of precedence

1. Annex VI

2. C&L Inventory

3. IUPAC

4. Other International name

5. Other (used in REACH notification, where IUPAC >100 characters)



REACH Compliant SDSs:What’s Coming … SUMIs, Eye Damage, Infocard, Poison Centres, Polymers, ISO 45001…



DU Sectors: Safe Use of Mixtures Information (SUMIs)

End use of mixtures with clearly defined markets

Sector-specific Worker Exposure Description (SWEDs)

One SUMI for each SWED

SUMI appended to or integrated within the SDS




Timeline for SWEDs and SUMIs

1Q 2016:

Sectors to publish their SWEDs and SUMIs

Development of Chesar input files for SWEDs

Train the trainer workshop June 2016

Publication Q4 2016


New Pictograms

Eye Damage Pictogram

Timeline?


Substance

Infocard

Timeline January

2016


Harmonised

Classifications

Assess suitability


CLP Article 45. Poison Centres

Receive information and give advice

Mixtures classified for physical and/or health hazards

Mixtures classified for environment only or non-hazardous mixtures with

hazardous ingredients are out of scope

Medical professionals only

Information received treated as confidential

https://poisoncentres.echa.europa.eu/

https://poisoncentres.echa.europa.eu/



Information submission

Harmonised information submission to each Poison Centre

Commercial mixtures, Industrial, Professional and Consumer Products

(R&D samples exempt)

Unique Formula Identifier (UFI)

Standard electronic format for submission (XML)

Group submission for similar mixtures with same hazard classification



Different Product use types

Limited submission for mixtures sold to industrial users providing 24/7 ER

system in place. Provide SDS

Full submission for mixtures sold to Professionals and Consumers

Reduced submission for mixtures used by Professionals in discussion?



Disclosure of Hazardous Ingredients

May need to disclose more info about hazardous ingredients than on

SDS

Disclosure at <0.1 wt.% for substances of major concern for emergency

health advice:

Acute Toxic 1, 2, or 3

STOT-SE or STOT-RE 1 or 2

Skin Corrosion 1, 1A, 1B or 1C

Serious Eye Damage 1

Exact wt.% preferred. Concentration range permitted



Disclosure of Non-Hazardous Ingredients

Commission proposal for all identified non-hazardous ingredients to be

disclosed down to 1 wt.%

Concentration range allowed



Unique Formula Identifier (UFI)

Possible solution:

Unique alphanumeric code linking submitted information to a specific

product

UFI generated FoC by notifiers using a web tool

UFI to be included on label or packaging for mixtures sold to

professionals and/or consumers

UFI only required on SDS for mixtures sold for industrial use


UFI format could be similar to batch number seen on mixtures



Timeline

REACH Committee vote 2016

Transitional period 3 years

2016 regulation in force (3Q?)

2019 Consumer and Professional use

2020 Professional use

2021 Industrial use



Updates to a notification

Change to mixture name

Change to mixture classification

Composition change

Submission without undue delay


Chemical Agents Directive 98/24/EC entry into force 1998

Amendment 2007/30/EC entry into force 2007

Amendment 2014/27/EU 2014

Assessing and Preventing Risk

Employers must take measures to eliminate or reduce risks to a minimum

Where possible chemicals or processes must be replaced with less

dangerous ones


A legal SDS?

A real world SDS?

Beware of jurisdiction obligations and culture


Non-Mandated SDS

Recommend 16 section REACH format for familiarity

Safety Information Sheet


• Established: 1999 local, global, presence

• Acquisitions: ESI Protheus, Telegis, etc

• 110+ professionals

• 850+ clients worldwide

• Industry Solutions : incl. Cosmetics/

Detergents/ Fragrances/ Petrochem

• Active in Chemical Federations

• C# / MS.NET4 with Microsoft SQL Server

• Easily integrates with printing and ERP

systems

• REACHReady, EIGA, Microsoft Gold

• Increased compliance efficiency

• Auto language/jurisdiction generation

• Auto SDS creation and management

• Simplified data management

• Easily integrates new regulatory lists

• Standardising safety data and work

processes

• All jurisdictions, GHS and non-GHS

• 50+ languages

• Easy to generate compliance reports

http://www.reachready.co.uk/

http://www.reachready.co.uk/

https://www.eiga.eu/

https://www.eiga.eu/


Simon Bradshaw, June [email protected]

Thank you. Questions?

REACH Compliant SDSs:What’s Changed and What’s Coming

mailto:[email protected]

http://www.lisam.com/

Documents

REACH Compliant SDSs: What’s - British Cleaning Councilbritishcleaningcouncil.org/wp-content/uploads/2016/07/Lisam-SDS... · • Acquisitions: ESI Protheus, Telegis, etc ... Detergents