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The sharp increase in reporting and com-munication requirements regarding the health, environmental and climate relevance of products means that an increasing num-ber of companies must now comply with international legislation such as EU-REACH, US Conflict Minerals and China RoHS.
This has an enormous impact on each and every
plant or subsidiary, as they all have to conduct their
own impact analyses to determine what they have to
test, communicate and document for substances,
mixtures and finished products.
The integrated process management module (iFlow)
of the iPoint Software Suite SAM-M (Substances,
Articles and Mixtures Management) manages the
processes for evaluating and managing such sub-
stance data. SAM-M takes into account both impact
analysis processes under REACH and Conflict Mine-
rals and risk management. These processes are vital
to meet increasingly complex and far-reaching legal
requirements and to define, implement and monitor
suitable risk management measures.
The situation
REACH and national legislations such as Germany's
Chemicals Act (ChemG) regulate the handling of
hazardous substances in mixtures and articles.
> REACH Annex XVII – governs bans and restric-
tions on the placing on the market of dangerous
substances, preparations and articles
> REACH Annex XIV – governs the authorization
of substances that give particular cause for con-
cern
> CLP Regulation – regulates protection from
dangerous substances (CLP/GHS Regulation)
> ChemGiftInfoV (Poisons Information Ordinance)
– ordinance on reporting requirements pursuant
to Section 16e of the Chemicals Act to prevent
poisonings and provision of information on such
incidents
SAM-M: Substance and risk management
SAM-M • Issue 12/2011
> ChemStrOWiV (Chemicals Penalty Ordinance)
– ordinance on the enforcement of Community
regulations governing substances and preparati-
ons
> FCKWHalonVerbV (German ordinance prohi-
biting the use of CFCs and halons) – ordinance
prohibiting certain halogenated hydrocarbons
that deplete the ozone layer
> Packaging Directive
> Biocide Directive
> Export/Import Directive – directive on the
import and export of hazardous chemicals
> Etc.
REACH and other international legislation regard the
Safety Data Sheet (SDS) as a binding communication
and occupational health and safety tool. Anyone
handling or placing hazardous substances or mixtures
on the market – as a manufacturer or importer –
must draw up such SDSs in accordance with REACH
and GHS/CLP and make them available free of char-
ge. Because REACH also regulates exposure scena-
rios for handling substances, the e-SDS is even more
important.
The e-SDS aims to provide industrial and commercial
users and private end consumers with the data they
need to handle substances and mixtures correctly
and safely. This relates to occupational health and
safety and environmental protection measures.
REACH also requires users to report products to the
European Chemicals Agency (ECHA) under certain
circumstances. In the case of “substances of very high
concern” (SVHC), for instance, or substances on the
ECHA list, information must be provided on their
safe handling and safe use in the supply chain.
The challenge
The person placing a product on the market is
responsible for ensuring that the safety data sheet is
technically correct and complete. The data sheet
must be regularly adapted and updated to reflect
current legal requirements and scientific develop-
ments. It is therefore important to consider changes
to the legal basis for substance properties and pro-
cessing procedures.
The user of the product is responsible for its safe use
in his facilities. Manufacturers, in turn, are obliged to
pass on information regarding REACH or US Conflict
Minerals within the supply chain. In a nutshell, all
players must identify their individual reporting requi-
rements in good time, fulfill them within the supply
chain and document them in accordance with the
relevant legislation.
Functions and aims
With SAM-M from iPoint-systems, REACH impact
analysis and US Conflict Mineral analysis are possible-
by mouse click. This solution automatically collects
basic data such as substances, mixtures and products,
enables granular management and optimizes the
associated internal and external communication.
SAM-M helps companies create legal certainty by:
> Defining roles
> Identifying critical substances and process condi-
tions
> Collecting substance data
> Collecting process data
> Identifying and evaluating current and future
requirements and competencies
> Defining and checking risk measures
> Reacting quickly and effectively in the event of
new laws or changes to existing laws
> Analyzing and quickly reacting to specific cus-
tomer requirements
> Analyzing and optimizing organizational struc-
tures
With the iPoint Supplier-Entry-Portal (SEP), SAM-M
offers enterprises the possibility of automated com-
munication via the company's own web portal. Safety
data sheets and other information such as certificates
or non-automotive component declarations can
therefore be sent and received efficiently.
The benefits of SAM-M at a glance
> Continuous monitoring of substance data in the company´s substance inventory in the event of legislative changes
> Detailed, role-based user management > User interface in German, English, French or Spanish > Modular design that can be scaled to achieve perfect sustainability solutions > Straightforward linking to ERP/PLM systems such as SAP, Oracle, Siemens Teamcenter and
others > Modular applications – ranging from solutions for stand-alone work stations to solutions for the
entire group > Flexible integration into existing system environments
Safety data sheet
iPoint SEP: Customized query-
ing and exchange of infor-
mation – for example, with
suppliers
Analysis Basic Substance
