Reach

REACH – European Regulation

“BUREAU VERITAS PROPRIETARY Copyright Bureau Veritas [2005]

Bureau Veritas – CHEMICAL COMPLIANCE REGISTER-REACH 1
DO NOT DISCLOSE OUTSIDE YOUR ORGANIZATION WITHOUT
BUREAU VERITAS PRIOR WRITTEN CONSENT”

What is REACH

REACH is about controlling risks to human health
and the environment that result from the use of
chemicals
REACH is about knowing what is in your products
REACH is about information communication
REACH is about controlling chemical
‘substances’, not products that contain them.



What is REACH

REACH
Regulation (EC) No 1907/2006
Effective Date: 1 June 2007 (Progressive schedule)

+ Pre-registration
Registration + Notification
Evaluation
Authorisation & restriction of
CHemicals


Overview of EU REACH Regulation

R egistration, E valuation, A uthorisation,
What does it stand for? and restriction of CH emicals

Designed to protect human health and
Purpose the environment

Staggered process over 11 years which involves the
Timeline Registration, Evaluation, Notification, Authorizations
and Restriction of Chemicals (REACH)

REACH is about knowing what substances are
In Essence in products and their impact on human health
and the environment



WHAT IS REACH?

DEFINITION SUBSTANCES versus PREPARATIONS versus ARTICLES

Individual pigments or single substance
SUBSTANCES
(Single Chemical with CAS/EC #) CAS # : Chemical Abstracts Service Number
EC # : European Chemical Number

PREPARATIONS
(Mixture or solution of two
or more substances)
Mixture pigments, solvents, ink,
concrete, etc
ARTICLES
Specific shape, surface or
design, which determines
its function to a larger
degree than its chemical Different components in an article.
composition
Packaging is a separate Article



Examples of substance

They are single
Ethanol
substances with EC#
EC#: 200-578-6 and CAS#
CAS#: 64-17-5

Sodium cyanide
EC#: 205-599-4
CAS#: 143-33-9

Copper sulphate
EC#: 231-847-6
CAS#: 7758-98-7



Examples of preparation

Glues Mixture of two or
more substances

Bleach

Dyes



Examples of preparation

Silica gel pack

All of above are PREPARATION in ARTICLE



Examples of article

Handbag
Object with specific
shape, surface or
design
Physical properties
determines its
Sandal function to a
greater degree than
its chemical
composition

T-shirt



Definitions

Intended release

The release is essential for the end use function of the article, and
without the release of the substances, the article would not work
sufficiently

Typical examples are : Joss sticks

The release contributes to a quality or minor function of the article,
or, in other words, the release contributes to an ‘added value’ of the
article, which is not directly connected to the end use function

Typical examples are : scented T-shirt and eraser



Examples of ADDED VALUE

The smell from the T-shirt is for adding value, not the end use function
of it Scented T-shirt

Peach smell
Grape smell



Definitions
SUBSTANCES OF VERY HIGH CONCERN (SVHC)

Generally effect the Environmental and or Human
Health
Persistent, Bio accumulative & Toxic (PBT’s)
Very Persistent & Very Bio accumulative (vPvB’s)
Carcinogenic, Mutagenic or toxic to Reproduction
There are 46 SVHC presently TOXIC / VERY TOXIC
/

Dangerous to Environment

HARMFUL / IRRITANT
/



Definitions

Only representative

With mutual agreement
Non-EU Manufacturer/ Producer
appoint a natural or legal person Have sufficient background
established in the Community to in the practical handling of
fulfil, as his only representative, the substance
the obligations on importers Have information related to
the substance
Shall keep the latest safety
data sheet

Non-EU EU

Manufacturer/ Only ECHA
Producer representative



REACH: Registration, Evaluation and Authorisation

The most important dates, from 1st Jun to 1st Dec 2008
Pre-Registration To benefit from staggered registration deadlines depending on the substances
and tonnage bands (2010, 2013, 2018)
Pre-register through a EU legal entity

Registration Registration applies to:
Substance in its own or in preparation
• Annual import to EU 1 tonne
Substance in articles
• Annual import to EU > 1 tonne
• Intended to be released under normal or foreseeable conditions of use
One Substance, One Registration (OSOR)

Evaluation Carried out by ECHA & member states based on risk – provides basis for
authorisation or restriction

Authorization Manufacturers, Importers and/or user of substances classified as SVHC need
Authorization - based on Annex XIV issued by ECHA in 2009



REACH: Restriction and Notification

Restriction REACH adopts restriction approach based on existing directives &
systems
A restricted substance shall not be manufactured, placed on the
market or used unless it complies with the conditions of that
restriction.

Notification If articles contain substances classified as SVHC, its manufacturers,
importers & or downstream users must notify ECHA regarding
its use if:
1. The substance is present > 1 tpa per producer or importer
2. The substance is present > 0.1 % weight by weight

3. The substance is classified as SVHC

Exemption can apply where exposure to humans or the environment
can be demonstrated



WHAT IS REACH?

REACH applies to many consumer product related
industries such as:
Chemicals
Dyeing
Printing
Soft lines
Softlines - textile and apparel Footwear
Footwear
Toys
Consumer electronics Hard lines
Household products
Other Consumer Products… Toys

Electrical


REACH EXEMPTIONS

Product categories exempt and covered under other regulations

Food, Feeding products, additives, flavourings and animal nutrition
Human and Veterinary Medicine and Pharmaceutical
Plant Protection and Biocides including fumigants, pesticides, herbicides
Radioactive substances
Waste (as defined in Directive 2006/12/EC)
Non-isolated intermediates of chemical production
Polymers excluded but monomers to be registered, if > 2% and 1 tonne p/a
Annex IV, water, carbon dioxide, carbon, glucose, etc.
Annex V, natural substances – ores, crude oil, minerals, coal, etc.



Scope of REACH

Who shall follow REACH Regulation?
• EU manufacturers and importers of substances on their own or
in preparations.
• EU producers and importers of articles.

• EU-based “only representatives” appointed by a manufacturer,
formulator or article producer outside the EU.

Failure to register a substance will mean it can not be used in
manufactured goods or placed on the market



Example of supply-chain obligation (registration)

Outside EU
EU Manufacturer A
Manufacturer A Manufacturer B registers
substance X
Substance Substance Manufacturer B
X Y registers
substance Y

Preparation VZ
Formulator C Formulators C & D
with no
obligation
Formulator D Preparation XY

Importer E
Preparation Importer E registers
XYVZ substances V&Z
Preparation
XYVZ


Registration Obligations



CONSUMER GROUPS ARE ALSO ACTING RAPIDLY

European Women Group promoting the New REACH legislation
and shoppers’ right to know what’s in their products



NGOs are also advising consumers what to write…
… will you be able to respond within 45 days?



REACH ENFORCEMENT

WHAT HAPPENS IF YOU GET IT WRONG?
Improvement notice
Legal action
• Fines
• Imprisonment

HOW DO YOU PROTECT YOURSELF?
Always consider the ‘spirit’ of REACH not just the words
Document every decision and reasoning
Be able to demonstrate that your know what substances are in your products
and that you are working with your supply chain



WHAT NEEDS TO BE DONE ?



REACH Key Dates …

Pre-registration (Legally recommended):
• Individual substances than 1 tonne/annum
• Substances in preparations than 1 tonne/annum
• Substances in articles than 1 tonne/annum and intentionally released
Pre-registration (Bureau Veritas recommended):
• For SVHC’s >0.1%w/w (1,000 mg/kg) in articles (Likely & Intended release)
• Monomers >2% w/w in polymers and than 1 tonne/annum
Registration

Registration of (if pre-registered): “Usage Specific”
1 tonne/year CMR’s (1+2)
For R50 & 53 classified substances than 100 tonne/annum (Toxic to aquatic)
1000 tonnes/year

100 tonnes/year

1 tonne/year
Registration of new substances (Non-phase in)
1 tonne/year
Annex XIV
will be Notification for SVHC in
pub- article: >1 tpa, and >0.1% (w/w)
lished

Authorisation for the
“use” of SVHC in EU



Decision for standalone SUBSTANCE or in a PREPARATION

Substance

Classified as
SVHC > 1 tpa

Authorization Registration



Decision for substances in an ARTICLE

Substance

Classified as
SVHC?
YES

> 0.1% (w/w)? > 1 tpa?

YES YES

Intentional
> 1 tpa?
release?
YES YES

Not
registered? Registration
YES

Notification


Registration according to Article 7(1) (and 7(5))

A registration (Article 7.1) of substances in articles is obligatory for an article
producer or importer only if the following conditions are met:

The substances are intended to be released from the produced or imported
article(s) during normal and reasonable foreseeable conditions of use

The total amount of the substance present in the articles with intended releases
produced and/or imported by that actor exceeds 1 ton per year per producer or
importer.



Notification according to Article 7(2)4

Notification of substances in articles is required when all conditions of Article
7(2) are met:

The substance is included in the candidate list (SVHC) for authorization
(Article 59(1)) and

The substance is present in all articles produced or imported by one actor in
an amount totaling over 1 tonne per year (per producer or importer)
The substance is present in articles above a concentration of 0.1% weight by
weight (w/w)



Obligations According to Article 33

The aim of Article 33 is to ensure that sufficient information is communicated
with articles to allow their safe use.
Producers, importers and other suppliers of articles containing substances of very high
concern (SVHC) included on the candidate list for authorization in a concentration
above 0.1% (w/w) have to provide respective information available to them to the
recipients of the articles and as a minimum the name of the substance.

There is no tonnage trigger for this obligation (i.e. it also applies below 1
tonne/a) and the obligation cannot be exempted neither via Article 7(3)
(exclusion of exposure) nor via Article 7(6) (already registered for that use).



Registration documentation
Registration documentation
Technical Dossier
- Identity of manufacturer/ importer
Substance - Identity of substance
to be - Info. on manufacture & use
registered - Classification & Labeling
- Guidance on safe use
- Substance properties (study summaries)
- Test proposal (if relevant)
- Exposure information

> 10 tpa Chemical Safety Report (CSR)
also - Hazard and PBT/vPvB assessment

Dangerous Chemical Safety Report (CSR)
/ - Hazard and PBT/vPvB assessment
PBT/vPvB also - Exposure assessment
Substance - Risk characterization


Authorization information

Substance(s) identity
Name & contact detail of applicant
A request, specifying the use(s) of the substance(s) needed
authorization
Chemical Safety Report if not registered
An analysis of substitution
A substitution plan if alternatives are available



Notification

If an article contains SVHC, its manufacturers, importers and/or
downstream users needs to notify the ECHA regarding of the use
of the substance, if both the following conditions are met:
• The SVHC is present > 1 tpa per producer/ importer;AND
• The SVHC is present > 0.1 % weight by weight;AND
• The SVHC has not been registered

After notification, ECHA may request registration, if
> 1tpa per producer/ importer
Release from article
Release of substance presents a risk to human health or the
environment



Notification information

Identity and contact detail of producer/ importer
Registration number if available
Substance identity
Substance classification
Description of the use(s) of SVHC in article
Tonnage range



YOUR OBLIGATIONS IN A NUTSHELL

Your obligations require you to identify
What substances are in your products
Intended release

Substances classified into categories – CMR, R50 & 53, Monomers >2% w/w in
polymers,

SVHC > 0.1%ww
Volumes of substances placed on the EU market

The precautionary principal and 45 day obligation
require you to
Demonstrate that you have done the exercise to know what is in your product

Be able to respond in 45 days to consumer questions asking what substances
are in products and if SVHC are present, then provide information on this.
(Article & Substance Safety Data Sheets)



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