New classification for formaldehyde and styrene: make

sure that your classification, label and safety data sheet

(SDS) are correct!
Following the publication of the 6th Adaptation to Technical Progress (ATP)
to the classification, labelling and packaging of substances and mixtures
(CLP) Regulation on 6th June 2014 (Regulation 605/2014), the existing
GHS harmonized classification has been modified for several substances,
including styrene and formaldehyde:

- Styrene is reclassified to toxic for reproduction category 2 and

specific target organ toxicity — single exposure, category 1;
- Formaldehyde is reclassified to carcinogenic category 1B and
mutagen category 2.

This new classification will enter into force on 1 April 2015. This means
new labelling and Safety Data Sheet requirements, as well as new REACH
obligations for formaldehyde (see details hereafter) have to be applied.
However, the Regulation 1297/2014 published on the 6th December 2014
specifies that the substances and mixtures placed on the marked before 1
June 2015 shall not be required to be relabeled and repackaged until 31
December 2015.

Do not forget that CLP will apply to mixtures from 1 June 2015, when the
basic requirements for substances and mixtures will be the same (there
will be a two-year grace period for mixtures already in the EU supply chain
on that date to be consumed).

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Styrene
Classification and labelling from 1/04/2015 (Regulation 605/2014):

Index N° International EC No CAS No Classification CLP Labelling CLP Specific Conc. Notes
Chemical Limits,
Identification M-factors
Hazard Class Hazard Pictogram, Hazard Suppl.
and statement Signal statement Hazard
Category Code(s) Word Code(s) statement
Code(s) Code(s) Code(s)
601-026- Styrene 202-851-5 100-42- Flam. Liq 3 H226 GHS02 H226 * D
00-0 5 Reprod. 2 H361d GHS08 H361d
Acute Tox. 4 H332 GHS07 H332
STOT RE 1 H372 Danger H372
Skin Irrit. 2 (hearing H315
Eye Irrit. 2 organs) H319
H315
H319

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Other presentation :

Styrene
Index N° 601-026-00-0
International Chemical Identification styrene
EC No 202-851_5
CAS No 100-42-5
Classification CLP Hazard Class and Hazard
Category Code(s) statement
Code(s)
Flam. Liq 3 H226 - Flammable liquid and vapour
Reprod. 2 H361d - Suspected of damaging the unborn child
Acute Tox. 4 H332 - Harmful if inhaled
STOT RE 1 H372 (hearing organs) - Causes damage to organs through
Skin Irrit. 2 prolonged or repeated exposure
Eye Irrit. 2 H315 - Causes skin irritation.
H319 - Causes serious eye irritation
Labelling CLP Pictogram Code(s)

GHS 02 GHS 08 GHS 07

Signal Word Dgr (Danger)

Hazard statement H226 - Flammable liquid and vapour
Code(s) H361d - Suspected of damaging the unborn child
H332 - Harmful if inhaled
H372 (hearing organs) - Causes damage to organs through
prolonged or repeated exposure
H315 - Causes skin irritation.
H319 - Causes serious eye irritation
Suppl.

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 Hazard statement
Code(s)

Specific Conc. Limits, *

M-factors An asterisk (*) in this column indicates that the
entry has specific concentration limits for acute toxicity
under Directive 67/548/EEC (Table 3.2).

Notes Note D:
Certain substances which are susceptible to spontaneous polymerisation or decomposition are
generally placed on the market in a stabilised form. It is in this form that they are listed in Part 3.
However, such substances are sometimes placed on the market in a non-stabilised form. In this
case, the supplier must state on the label the name of the substance followed by the words ‘non-
stabilised’.

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Formaldehyde
Classification and labelling from 1/04/2015 (Regulation 605/2014)

Index N° International EC No CAS No Classification CLP Labelling CLP Specific Conc. Limits, Notes
Chemical M-factors
Identification
Hazard Class Hazard Pictogram, Hazard Suppl.
and statement Signal statement Hazard
Category Code(s) Word Code(s) statement
Code(s) Code(s) Code(s)
605-001- Formaldehyde 200-001-8 50-00-0 Carc. 1B H350 GHS08 H350 * Skin Corr. 1B; H314: B, D
00-5 …% Muta. 2 H341 GHS06 H341 C ≥ 25 %
Acute Tox. 3* H301 GHS05 H301 Skin Irrit. 2; H315: 5
Acute Tox. 3* H311 Danger H311 % ≤ C < 25 %
Acute Tox. 3* H331 H331 Eye Irrit. 2; H319: 5 %
Skin Corr. 1B H314 H314 ≤C < 25 %
Skin Sens. 1 H317 H317 STOT SE 3; H335: C ≥
5%
Skin Sens. 1; H317: C
≥0,2 %

Main consequences of this new classification of formaldehyde:

- All Category 1 carcinogens manufactured or imported at 1 tonnes or more per year were to be registered by the 1st December 2010. With
reclassification as a known carcinogen, formaldehyde producers and importers will have to immediately submit registration dossiers when the
classification becomes legally binding. The first step is to introduce an inquiry dossier at the level of ECHA followed after the sameness check of
ECHA by a formal registration dossier linked to the existing registration.
- As a Category 1 Carcinogen formaldehyde may be proposed as substances of very high concern (SVHCs) in the REACH Annex XIV Candidate list, for
eventual inclusion in the Authorisation List. Further restrictions may also apply, especially for use in some consumer products;

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 - As a Category 1 carcinogen, formaldehyde use will be regulated by the Carcinogens Directive in EU workplaces. The central concept of this directive
is that worker exposure to the substance is as low as technically possible, using the hierarchy of prevention;

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Other presentation :

Formaldehyde
Index N° 605-001-00-5
International Chemical Identification Formaldehyde …%
EC No 200-001-8
CAS No 50-00-0
Classification CLP Hazard Class and Hazard
Category Code(s) statement
Code(s)
Carc. 1B H350 - May cause cancer by inhalation
Muta. 2 H341 - Suspected of causing genetic defects
Acute Tox. 3* H301 - Toxic if swallowed
Acute Tox. 3* H311 - Toxic in contact with skin
Acute Tox. 3* H331 - Toxic if inhaled
Skin Corr. 1B H314 - Causes severe skin burns and eye damage
Skin Sens. 1 H317 - May cause an allergic skin reaction
Labelling CLP Pictogram Code(s)

GHS 08 GHS 06 GSH 05

Signal Word Dgr (Danger)

Hazard statement H350 - May cause cancer by inhalation
Code(s) H341 - Suspected of causing genetic defects
H301 - Toxic if swallowed
H311 - Toxic in contact with skin
H331 - Toxic if inhaled
H314 - Causes severe skin burns and eye damage
H317 - May cause an allergic skin reaction
Suppl.

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 Hazard statement
Code(s)

Specific Conc. Limits, * Skin Corr. 1B; H314: C ≥ 25 %

M-factors Skin Irrit. 2; H315: 5 % ≤ C < 25 %
Eye Irrit. 2; H319: 5 % ≤C < 25 %
STOT SE 3; H335: C ≥ 5%
Skin Sens. 1; H317: C ≥0,2 %
Notes Note B:
Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various
concentrations and,therefore, these solutions require different classification and labelling since the
hazards vary at different concentrations.
In Part 3 entries with Note B have a general designation of the following type: ‘nitric acid … %’.
In this case the supplier must state the percentage concentration of the solution on the label.
Unless otherwisestated, it is assumed that the percentage concentration is calculated on a
weight/weight basis.
Note D:
Certain substances which are susceptible to spontaneous polymerisation or decomposition are
generally placed on the market in a stabilised form. It is in this form that they are listed in Part 3.
However, such substances are sometimes placed on the market in a non-stabilised form. In this
case, the supplier must state on the label the name of the substance followed by the words ‘non-
stabilised’.

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CLP labelling for free formaldehyde in mixtures1
The labeling requirements vary with specific concentration limits:

<0.1% none
≥ 0.1 % - < 0.2 % Pictogram Code(s)

GHS 08 GHS 07

Signal Word Dgr (Danger)

Hazard statement H350 - May cause cancer by inhalation
Code(s)
Supplemental label elements/information on EUH 208 : contains formaldehyde. May produce an
certain substances and mixtures allergic reaction
≥ 0.2 % - < 1 % Pictogram Code(s)

GHS 08 GHS 07

Signal Word Dgr (Danger)

Hazard statement H350 - May cause cancer by inhalation
Code(s) H317 - May cause an allergic skin reaction
≥1%-<5% Pictogram Code(s)

GHS 08 GHS 07

Signal Word Dgr (Danger)

Hazard statement H350 - May cause cancer by inhalation
Code(s) H317 - May cause an allergic skin reaction
H341 - Suspected of causing genetic defects
1
Reference: Formacare (source: BASF)
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≥ 5 % - < 25 % Pictogram Code(s)

GHS 08 GHS 07

Signal Word Dgr (Danger)

Hazard statement H350 - May cause cancer by inhalation
Code(s) H317 - May cause an allergic skin reaction
H341 - Suspected of causing genetic defects
H315 - Causes skin irritation.
H319 - Causes serious eye irritation.
H335 - May cause respiratory irritation
≥ 25 % Pictogram Code(s)

GHS 08 GHS 05 GHS 06

Signal Word Dgr (Danger)

Hazard statement H350 - May cause cancer by inhalation
Code(s) H317 - May cause an allergic skin reaction
H341 - Suspected of causing genetic defects
H314- Causes severe skin burns and eye damage
H331 - Toxic if inhaled2
H335 - May cause respiratory irritation3
H301 - Toxic if swallowed4
H311- Toxic in contact with skin5

2
according to specific concentration limits of 67/548/EEC. Corresponding concentration limits do not exist under CLP. Mixture classification should be calculated in line with CLP regulation Annex I, chapter 3.1.3.
3
No upper limit is stated for the H335 in the CLP regulation
4
according to specific concentration limits of 67/548/EEC. Corresponding concentration limits do not exist under CLP. Mixture classification should be calculated in line with CLP regulation Annex I, chapter 3.1.3.
5
according to specific concentration limits of 67/548/EEC. Corresponding concentration limits do not exist under CLP. Mixture classification should be calculated in line with CLP regulation Annex I, chapter 3.1.3.
EuCIA  Diamant Building – 80 Bd. A. Reyers Ln.  BE-1030 Brussels  Belgium
Tel. +32 2 706 89 06  [email protected]  www.eucia.eu
BTW BE 0828.952.496  BE72 3631 2058 8016 - BIC xxxxxxxx