REACH Registration, Evaluation and Authorization of Chemicals

ELANTAS Italia S.r.l.: ahead in time with Reach.

ELANTAS Italia S.r.l. Strada Antolini, 1 I-43044 Collecchio (Parma), Italia

Subject: Commitment of ELANTAS Italia S.r.l. towards new Reach Regulation ELANTAS Italia S.r.l operates with an integrated system of Quality, Safety and Environment. As we are associated with Federchimica (the Italian partner of Cefic) we take an active part in the initiatives for a safe and clean chemical industry like Responsible Care ® and SET. Pursuing Health, Safety and Environmental Protection targets is an integral aspect of all the company’s plans and is visible in all internal processes such as training of personnel on safety on the workplace. 1st June 2007 new REACH regulation came into force. It is the result of a long and complex process that will replace most of existing EU legislation on chemicals. The Management of ELANTAS Italia S.r.l fully agrees with the overall objectives of REACH. We express the firm commitment to sustain the entire sales products portfolio under the obligations of REACH, in an effort to continue to serve ELANTAS Italia current and future customers. ELANTAS Italia has been very active in preparation for Reach since the beginning of this long process which started in the late nineties. ELANTAS Italia has identified the critical raw materials in productions. Direct contact and continuous dialog with suppliers permitted to collect all necessary information. We will provide our customers with all relevant information about our activities related to the implementation of REACH. Because of the complexity of REACH, however, no formal guarantees can be made that indeed all individual products will be sustained under all circumstances.

Date: 01/01/2012 Page: 1/1 Your contact: Antonio Nastasi Tel: +39 0736 3081 Fax: +39 0736 402746 E-mail [email protected] ELANTAS Italia S.r.l. Sede legale: Strada Antolini, 1 43044 Collecchio (PARMA) – Italy Registered Partita IVA: 01356800449 CF/Registro Imprese: 10732750152 Capitale Sociale € 2.080.000 int. Vers ELANTAS Italia è una società soggetta all’attività di direzione e coordinamento di ELANTAS GmbH, ai sensi dell’art. 2479/bis C.C.

ELANTAS Italia S.r.l General Manager Antonio Nastasi

A member of

Activities of ELANTAS Italia and ALTANA in anticipation to REACH

REACH is the acronym for Registration, Evaluation and Authorization of CHemicals. It is the new EU

In ELANTAS Italia a specific ‘Reach implementation project’ has been started in time, to comply with all legal requirements. A working group has been formed and new resources have been assigned to this project: E H&S , purchasing, research & development and sales people cooperating directly with the management board have been actively participating to implementation. Only

(European Union) legislation for chemical substances that came in force the 1st of June 2007. REACH will apply to the manufacture and marketing (including import from outside the EU) of substances, on their own or in mixtures or in articles.

such a skilled team could deal with this complex legislation.

Reach is one of the major issues also for the ALTANA management board who started an official, highest

ELANTAS Italia S.r.l.

priority, ALTANA project for the implementation of

participates to the

REACH.

Responsible Care

The project manager is Dr. Diez, Vice President Corporate EH&S reporting directly to ALTANA's CEO Dr. Wolfgruber. All EU manufacturing sites of ALTANA are involved in the project with responsible people. The core team of the project includes more than 25 employees including purchasing and IT. Regular meetings of the core team as well as seminars and specific IT tools make sure everything is in time and everybody has the necessary information.

The team has collected the data to make sure all substances are pre-registerd and registered and to plan new resources and budget. The core team will be supported by further members as necessary like sales for the communication with customers.

Being a company member of ALTANA, ELANTAS Italia participates to all the initiatives of the central E H&S.

Sinergy between sister companies helps in getting ready for Reach.

®

program and SET

Useful links: -http://ec.europa.eu/echa -http://www.reachcentrum.org -http://www.cefic.org

Dr. Diez during a conference at European Parliament

Which chemicals are subject to REACH?

The main consequences of REACH will be:

REACH only applies directly to substances that

•

replacement of most existing EU legislation

are produced / imported in quantities exceeding 1

on chemical substances, including the

metric ton per annum.

EINECS inventory

Substances are essentially chemical compounds

•

the creation of a European Chemicals

that are obtained by any manufacturing process:

Agency (ECHA) that will be located in

they can be sold as such or mixed together in a

Helsinki

formulation to form a preparate. Indirectly, in fact REACH will have a major impact

•

a so-called ‘paradigm change’; this means

on preparates; on articles only if they intentionally

that the responsibility will be on the

release substances.

industry (with help from the Agency), not on the authorities

Non-isolated intermediates (and hence not marketed as such) are outside the scope of

•

risk communication throughout the entire

REACH. Isolated intermediates and transported

supply chain: manufacturer / importer >

intemediates are subject to REACH, but reduced

formulator > downstream user (DU)

registration requirements apply to these. • The most important categories of substances

all substances subject to REACH will have to be registered

exempt from REACH are: •

• polymers (if monomers presents >2% are

to be evaluated based on physical /

registered!). •

all substances subject to REACH will have

chemical, toxicological and ecotoxicological

biocides, medical products, food and

data for their identified uses

feedstuffs, and cosmetic products (as they are already subject to other strict legal obligations).

•

wastes

•

high-risk substances will be subject to authorization, which will result in restrictions and bans for these identified uses where the risks cannot be adequately managed.

December 2006: Altana Reach Meeting in Nurmberg

Pre-Registration

Registration st

The Agency is will be operative since 1 June 2008

Only chemicals with EINECS or NLP numbers (phase-

and the so called pre-registration phase is started. The

in substances) could be pre-registered. Others (non

pre-registration comprises essentially the name of the

phase-in) should be registred directly, starting from 1

manufacturer / importer, the identity of the substance

June 2008.

st

and the weight band. After pre-registration, registrants that have registered There are four different weight bands which correspond

the same substance have to share available data to

to the annual production/import per each manufacturer

avoid animal testing (especially vertebrates).

/ importer: Registration will have to take place in three priorities •

1-10 tons per annum

•

10-100 tons per annum

•

100-1.000 tons per annum

During registration, not all actual test data has to be

•

above 1.000 tons per annum

submitted – only so-called robust summaries for a

(see timetable for deadlines).

certain number of end points – the exact end points These weight bands correspond to the data that have

depend upon the volume band of the substance

to be used for the evaluation and are also used to

involved.

prioritize substances. A second criterion in addition to volumes is used:

Further, for substances in volume bands exceeding

whether the substance belongs to ‘high-risk’

100 tons per annum, only proposals for the actual

categories. These comprise:

testing is required at this stage. These have to be approved by the Agency prior to the actual generating

•

CMR substances class 1 and 2 (carcinogenic,

of the data.

mutagenic and reprotoxic) •

vPvB and PBT substances (very persistent

Also, the registrant has to submit general information

and very bio-accumulating and persistent,

regarding the exposure and risk management

bio-accumulating and toxic respectively).

measures for the identified uses (see below).

Data required for evaluation

Identified use and exposure

The data required for evaluation is the result of

Identified use, a key concept of REACH, is a new

the decisions after registration, i.e. the reviewing

concept in the EU legislation for chemical

by the Agency of the proposals for further testing.

substances. It means that the registration, evaluation (and authorization, if applicable) are

The data required, again, depends on the volume

use-specific, as the safety assessment not only

band for the substance (for the producer /

takes the hazard (intrinsic substance property),

importer or, when applicable, the consortium of

but also the exposure (of humans or the

producers / importers for the substance involved).

environment) into consideration.

Essentially, the costs involved comprise of:

For this, the basic concepts are: •

•

technical dossier

•

chemical safety assessment (CSA, only for

•

exposure scenarios (or use categories in combination with exposure categories)

•

exposure assessment risk management

substances above 10 tons per annum)

measures (which are, of course, use-

chemical safety report (CSR, only for

specific)

substances above 10 tons per annum) •

extended safety datasheet

The generic use categories are:

•

registration (plus, if applicable, authorization)

•

industrial use

costs (these depend on the volume band)

•

professional use

•

consumer use

In future “no data, no market” will be the basic

Specifications for industrial use are:

rule for safe chemistry within Europe.

•

used in closed system and / or

•

use resulting in inclusion into or onto matrix and / or

•

non-dispersive use and / or

Authorization

•

dispersive use

Authorization may be required if a substance

Significant route(s) of exposure are:

has data that shows that the substance is or is

•

reasonably suspect to have either

or inhalatory) •

•

PBT or vPvB or CMR or endocrine disrupting (= influencing hormonal interactions) properties.

human exposure (oral and / or dermal and /

environmental exposure (water and / or air and / or solid waste and / or soil)

•

pattern of exposure (accidental / infrequent and / or occasional and / or continuous / frequent)

Authorization, like registration, is identified usespecific and however, is probably going to be limited in time, with regular reviews and possibly with a substitution obligation within a well-defined period of time.

Timetable and deadlines

since 1st June 2007 REACH regulation is in force within European Community

01/06/2008 – 30/11/2008 pre-registration (*) of ‘phase-in’ substances

Information along the supply chain

01/06/2008 registration of ‘non phase-in’ substances and new

Not only will the final position of REACh have a major

chemicals

impact on how to conduct the chemical safety assessment (exposure parameters have to be generated in order to be taken into account!), but this would also result in highly complex and lengthy (so called “enhanced”) material safety data sheets.

until 01/12/2010 registration of all phase-in substances: •

above 1.000 tons per annum and

•

all substances classified N, R50-53 above 100 tons per annum and

REACH recognizes two distinct levels along the supply •

chain:

all CMR (class 1 and 2) substances and PBT and vPvB substances and endocrine

•

manufacturer / importer

•

formulator / downstream user until 01/06/2013

The means of communication between these levels is

registration of all substances above 100 tons per

the material safety data sheet through which the

annum

various data will have to be communicated.

It is important for both the formulator and the

until 01/06/2018

downstream user to check whether their identified use

registration of all other substances above 1 ton

is included. If it is, they have to check whether the

per annum

exposure parameters are being complied with and whether the risk management measures are being affected.

If the identified use is not included, the formulator / downstream user has two options:

(*) substance not pre-registered > production / import stopped

1.

to do their own chemical safety evaluation or

2.

to ask their supplier to do this for them.

http://www.elantas.com/elantas-italia ELANTAS Italia plants: Strada Antolini, 1 - 43044 - Collecchio (PR) - Italy Tel. +39 0521 304711 – Fax. +39 0521 804410 Zona Industriale Campolungo, 35 63100 – Ascoli Piceno - Italy Tel. +39 0736 3081 – Fax. +39 0736 402746 Via San Martino, 6 15028 – Quattordio (AL) - Italy ELANTAS Italia S.r.l focal Point REACh [email protected]

Tel. +39 0131 773870 – Fax. +39 0131 773875