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Integrated Supply Chain Information
7 Safety Data Sheets and EU Eco-Label
Safety data sheets are part of the picture regarding environmental and health product chain information. SDS is the legislative obligatory instrument for passing information regarding hazardous properties of
chemical products and information, how to handle such products safely within the professional part of the product chain. In that way SDS's for chemical products are comparable with EPD's for products in
general.
Based on selected product groups (paints/varnishes, washing and cleaning agents), the SDS scheme is analysed for the possibility of supporting relevant data to be used for eco-label documentation. The
criteria for paint and varnishes and universal cleaning agents are used as examples of products containing chemicals, or put in another way, as examples of products, which are not articles, as there is
(presently) no demand for preparation of safety data sheets for articles.
Documentation with regard to eco-labels is in this context defined as the documentation to evaluate whether the product complies with criteria in a given set of eco label criteria and not as the documentation
to establish the criteria.
The data need for safety data sheets is outlined in section 3.1.2.
The SDS directive is expected to be amended in the near future due to the upcoming new EU chemical regulation REACH. As REACH is expected to extend the requirements in SDS for information on
recommended uses and how chemical products may be used without significant risk to man and environment, a short outline of REACH is presented below.
7.1 Safety data sheets and the new chemical regulation (REACH)
The Commission has brought forward a proposal for a new chemical regulation among others intended to increase product chain information regarding chemical products and articles to liberate chemicals
during use and disposal. In addition to the present information included in SDS, the new regulation requires information on how the product may be used by down stream users so that environment and health
are not at risk. The legislation is expected to be adopted in 2006/07.
7.1.1 The new EU Chemicals regulation (REACH)
On 29th October 2003, the European Commission adopted a proposal for a new EU regulatory framework for chemicals. [8] Under the proposed new system called REACH. REACH stands for:
Registration, Evaluation and Authorisation of CHemicals and will replace 40 different pieces of legislation including the current Safety Data Sheet Directive (91/155/EEC). The proposal is based on the
White Paper on the Strategy for a Future Chemicals Policy, which was published by the Commission in Februaryy 2001 and the results of a hearing process.
Under REACH, enterprises that manufacture or import more than one ton of a chemical substance per year would be required to register it in a central database. The aims of the proposed new Regulation
are to improve the protection of human health and the environment while maintaining the competitiveness and enhancing the innovative capability of the EU chemicals industry. REACH would furthermore
give greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. This information should be passed down the product chain. The proposal is now
being considered by the European Parliament and the Council of the EU for adoption under the so-called co-decision procedure. [9]
The demands of REACH depends on the marketed tonnage of the substance and the level of concern:
- Registration (> 1 t/year/producer)
- Evaluation (> 100 t /year of substances of concern)
- Authorisation (substances of very high concern)
7.1.2 Registration
All companies manufacturing substances in, or importing substances into, the EU in quantities of 1 ton or more per manufacturer or importer per year must submit relevant information to the Agency before
new substances are marketed. Registration requires collection of information on the manufactured or imported substance. The information collected should be used for responsible and well-informed
management of the potential risks of the substance and should be documented in their Chemical Safety Report. The information required increases at the tonnage thresholds of 10, 100 and 1000 tonnes
respectively, and is describes in Annexes V to VII in the REACH regulation.
If information required for substances manufactured or imported in quantities of 100 tonnes and more is not available, testing proposals to meet these requirements will have to be submitted as a part of the
registration.
7.1.3 Evaluation
Evaluation of substances > 1000 t/year: Industry prepares a registration dossier and proposal of further testing if needed and forwards this to the authorities. Authorities evaluate the information and the
proposal for further testing in order to ensure that appropriate tests will be performed and double testing is avoided.
7.1.4 Authorisation
All use of substances with intrinsic properties of very high concern will have to be authorised.
Such substances of very high concern are:
- category 1 and 2 CMR's
- substances which are persistent, bioaccumulative and toxic (PBT)
- substances which are very persistent and very bioaccumulative (vPvB)
- other substances, such as endocrine disruptors, that present an equivalent level of concern
To obtain an authorisation, a manufacturer, importer or down-stream user will have to demonstrate that the risk from the use of a substance can be adequately controlled, or that the socio-economic benefits
outweigh the risk.
7.1.5 Restrictions
Any substance may be subject to restrictions regardless of whether they are subject to registration or not.
7.1.6 The Chemical Safety Report (CSR)
A chemical safety report (CSR), including a chemical safety assessment and details of risk management measures, is required for registrations of substances manufactured or imported in quantities starting at
10 tonnes per year by a manufacturer or importer.
CSA for a substance
The chemical safety assessment must address all identified uses. It must consider the use of the substance on its own, in a preparation or in an article. The assessment must consider all stages of the lifecycle
of the substance as defined by the identified uses. The chemical safety assessment must be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable
exposure of man and/or the environment to that substance.
The information to be considered includes information related to the hazard of the substance, the exposure arising from the manufacture or import and the identified use of the substance.
The main element of the exposure part of the chemical safety report is the description of the manufacturer's or importer's exposure scenario(s) and the exposure scenario(s) recommended by the
manufacturer or importer to be implemented for the identified use(s). The exposure scenarios contain a description of the risk management measures which the manufacturer or importer has implemented and
recommends to be implemented by downstream users. If the substance is placed on the market, these exposure scenarios including the risk management measures must be summarised in an annex to the
safety data sheet.
CSA for a preparation
The Chemical Safety Assessment for a preparation must be based on the information on the individual substances in the preparation contained in the Technical Dossier and/or the information communicated
by the supplier in the safety Data Sheet. It must also be based on the information for the preparation itself.
7.1.7 New requirements for the content of the Safety Data Sheet
Annex 1a in REACH sets out the requirements for a safety data sheet. The safety data sheet provides a mechanism for transmission of appropriate information in the relevant CSR's down the supply chain to
the immediate downstream users. The information provided in the safety data sheet must be consistent with the information in the CSR, where required.
According to REACH, the importer or manufacturer must prepare an annex to the safety data sheet, which must contain exposure scenarios and describe appropriate risk management measures for the
identified use in a lifecycle perspective. This information must be based on the Chemical Safety Assessments prepared by the importer or manufacturer.
7.1.8 Information in the supply chain
The Commission has initiated a number of Reach Implementation Projects (RIP) to elaborate background documents for explaining the procedures to be followed regarding the various parts of REACH. Of
special interest for supply chain information is the types of use information down stream users are expected to pass on to their suppliers and how articles are to be included in REACH.
For eco-labels and EPDs it is interesting to note that when REACH is fully implemented (11 years after adoption) hazard information for all dangerous substances should appear in the SDS. Also information
regarding supported use and how risks may be prevented should appear. SDS's are therefore expected to include sufficient information to be used as documentation regarding eco-label criteria compliance in
future.
It is anticipated by the Commission that REACH will lead to an important market pressure against substances where stringent risk management measures are needed or where the uses is very restricted (high
risk identified, substances under authorisation). Eco-labels and EPDs may have a role to facilitate this market effect.
7.2 Comparison of data requirements for SDS and EU Eco-label (indoor paints and varnishes)
Table 9 lists the criteria for assignment of the EU eco-label for indoor paints and varnishes and the presence of this information in SDS.
Table 9 Comparison of EU Eco-label criteria for paint and varnish and the information in SDS'. The numbers in the first column refers to the numbering of the criteria document [10].
The EU
Eco-label
Paint/Varnish |
The EPD/PCR
Chemical Products |
| 1a |
White pigments: The content of white pigments in paint must be 38 g/m² or lower |
No information |
| 1b |
Demands for emission and discharge of waste from production of the pigment titanium dioxide |
No information |
| 2 |
Volatile organic compounds: The limit for content of VOC e.g. max 30 g/l for wall paints |
To the extent that they must be declared, the content of VOC compounds will be
stated in section 2 and the limit value for certain VOC compounds must be stated in
section 8. |
| 3 |
Volatile aromatic hydrocarbons: The limit for VAH e.g. max. 0.15 % for wall paints |
To the extent that they must be declared, the content of VAH compounds will be
stated in section 2 and the limit value for certain VAH compounds must be stated in
section 8 |
| 4 |
Heavy metals: Ban against content of the heavy metals Cd, Pb, Cr (VI), Hg, As |
If the content exceeds certain limits, this must be declared in section 2. No
declaration of the non-appearance of the substances |
| 5a |
Dangerous substances: The product shall not belong to hazard classes “Very toxic” (Tx), “Toxic”
(T), CMR [11] cat.1 and 2 or “Dangerous to the environment (N) |
The classification of the product can be seen in section 15 of the safety data sheet |
| 5b |
Ban against the use of ingredients classified as ”Very toxic”, ”Toxic” which have been or may be
awarded one or more of the following R-phrases or combinations thereof: R23, R24, R25, R26, R27,
R28, R39, R45, R46, R48, R60 or R61. Active ingredients with R23, R24, R25, R26, R27, R28,
R39 and R48 are, however, allowed up to 0.1 %. |
The content of these substances will be stated in section 2 if they comprise 0.1 % or
more of the product. |
| 5c |
Ingredients with: R50, R51, R52, R53 or combinations thereof may each only comprise 2.5 % of the
product and combined no more than 5 %. |
The content of such substances will be stated in section 2 if they comprise ≥ 0.1 % of
the product when classified with R50 and R51 and/or ≥ 1 % for substances classified
R52/53 or R53. [12] |
| 5d |
The product may not contain APEO |
APEO-compounds are usually classified as “Dangerous for the environment” and the
content will therefore be stated in section 2 if it is equal to or exceeds 0.1 % |
| 5e |
The product may not contain diethylenglycol methylether (DEGME CAS-nr: 111-77-3) |
The substance is classified Rep3;R63 and will therefore have to be declared at a
content corresponding to 1 % or above |
| 5f |
The content of isothizolinone compounds may not exceed 500 ppm. The content of kathon may not
exceed 15 ppm |
The limit for content of kathon corresponds to the classification limit. Content of 15
ppm or above will therefore have to be stated in section 2 of the safety data sheet.
The declaration limit for other isothiazolinone compounds depends on the
classification of the substances |
| 5g |
The content of free formaldehyde may not exceed 10 ppm (=0.001 %) |
Formaldehyde must be stated in section 2 if the content is 0.1 % or above |
| 6 |
Fitness for use: Demands for durability, scrubbing resistance, resistance to water and adherence |
No information. Parameters such as durability, resistance and wearability are usually
stated in the technical information |
| 7 |
Consumer information: Information on purpose, cleaning instructions for painter's tools and removal
instructions for waste. In addition, information on storage after opening including safety instructions if
relevant as well as preventive safety precautions for the painter |
This information must be stated in sections 7, 8 and 13 of the safety data sheet |
| 8 |
Information appearing on the eco-label: Box 2 of the eco-label shall contain the following text:
“Good performance for indoor use, hazardous substances restricted, low solvent content |
- The eco-label is not usually depicted in the safety data sheet but rather on the
packaging of the product as well as sales material such as brochures etc. |
As it appears from table 9, some of the information needed to apply for an eco-label may be obtained from the product's safety data sheet, but the safety data sheet cannot be used in its present form as the
sole basis for an application for an eco-label. However, they can to an extent be used to estimate whether an indoor paint or varnish is qualified to obtain an eco-label, particularly if the information is
supplemented with the information that will typically be given in the technical data sheet.
A common denominator for the two systems is that detailed composition information, i.e. the recipe of the product, is needed. The documentation for the eco-label may e.g. have to be supplemented by an
analysis documenting the absence of heavy metals or that the content of free formaldehyde is less than 10 ppm. In practice, this documentation is most often delivered by the supplier in the form of a (verified)
certificate.
Should the SDS technically be able to deliver the appropriate documentation, the following information should be included (requested from the supplier). It is important to note, that there are no hindrance in
the legislation regarding such additional information to be included.
- Content of white pigments
- Content of total VOC in g/l
- Content of VAH in g/l
- Limits for e.g. content of formaldehyde and isothiazolinone compounds. Alternatively, it may be supplemented by a section specifying the absence or level of certain ingredients (AEPO,
diethylenglycolmethylether, formaldehyde etc.).
- Technical qualities, including information on durability, scrubbing resistance, resistance to water and adhesive qualities.
- LCA-related information, including emissions and discharge of waste during the production of titanium dioxide.
Should the product be in compliance with and be awarded the eco-label, the logo may be reproduced in the safety data sheet, for example in section 16.
7.3 Comparison of data requirement (All purpose cleaners)
In table 10 the same type of information is compiled for all -purpose cleaners as above for paint and varnish.
Table 10 Criteria for all-purpose cleaners compared with information in the safety data sheet. The number in the first column refers to the numbering of the criteria document [13]
(2005-2008).
The EU
Eco-label
All-purpose
cleaners |
Safety Data Sheet |
| |
All purpose cleaners must have water content ≤ 90 % (w/w) (Article 1a) |
Could be stated in section 2 |
| 1 |
Toxicity to aquatic organisms: The critical dilution volume for the product, toxicity (CDVtox) may not
exceed 20000 l/functional unit [14] |
No information. Could be stated in section 12 [15]. |
| 2a |
Biodegradability of surfactants: Aerobic: Each surfactant used in the product shall be readily biodegradable |
Could be stated in section 12 of the safety data sheet |
| 2b |
Anaerobic biological decomposition: Each surfactant used in the product shall be biodegradable under
anaerobic conditions (minimum 60%) |
Could be stated in section 12 of the safety data sheet |
| 3a |
Dangerous hazardous or toxic substances or preparation: Ban on the use of:
- Alkyl phenol ethoxylates (APEO) and APEO derivatives
- Nitro musk and polycyclic musk
- EDTA
- NTA
|
Declaration in section 2 depends on the classification of the substances and the
amount in which they are contained in the product |
| 3b |
Ban on use quaternary ammonium compounds that are not readily degradable |
Could be stated in section 12 of the safety data sheet |
| 3c |
May not contain ingredients classified with: R31, R40, R45, R46, R49, R68, R50/53, R51/53, R59, R60, R61, R62; R63, R64 in amounts of more than
0.01 %. Specific requirements are prescribes for biocides see 4 below |
If it exceeds certain limits, the content will have to be declared in section 2.
[16] |
| |
The EU Eco-label
All-purpose cleaners |
Safety Data Sheet |
| 4 |
Biocides:
The product may only include biocides in order to preserve the product, and in appropriate doses for this
purpose alone. It is prohibited to claim and suggest that the product has an antimicrobial action. Biocides classified with R50-53 or R51-53 risk phrases may not be potentially bioaccumulative.
The concentration of biocides in the final product shall not exceed the maximum authorised concentration in
the Council Directive 76/768/EEC (Cosmetic directive) |
Declaration in section 2 depends on the classification of the substances and the
amount in which they are contained in the product |
| 5 |
Dyes or colouring agents: Any dyes or colouring agents used in the product must be permitted by the cosmetics legislation or regulation on colours for use in foodstuffs< [17], or must be characterised by
environmental properties that do not imply classification with R50/53 og R51/53 |
No information. |
| 6a |
Fragrances: The product may not contain perfumes with nitro musk or polycyclic musk as specified under
3a. See also section 7 |
See section 3a. |
| 6b |
Any scent must be produced and handled according to code of practice of the International Fragrance
Association |
No information |
| 7 |
Sensitising substances: The product may not be classified with R42 and/or R43. The content of substances
classified with R42 and/or R43 may not exceed 0.1 % by weight of the final product |
Classification of the product with R42 and/or 43 is immediately apparent from
section 15 of the safety data sheet. There is no demand that ingoing substances with R42 and/or R43 in
concentrations below 0.1 shall be stated in section 2 |
| 8 |
Volatile organic compounds: May not contain more than 10 % volatile organic compounds with a boiling
point lower than 150ºC |
The content of volatile organic compounds will, to the extent they are
contained in amounts of more than 1 %, have to be declared in section 2 and
the limit value for certain volatile compounds must be stated in section 8 |
| 9 |
Phosphorous: The total content of phosphorous (P) may not exceed 0.02 g/functional unit. |
No information |
The EU Eco-label
All-purpose cleaners |
Safety Data Sheet |
| 10a |
Packaging requirements: Ban against propellants |
No information |
| 10b |
Plastic goods must be labelled according to specific regulations [18] |
No information |
| 10c |
If the primary packaging consists of reused materials, statements of this must comply with ISO 14021 |
No information |
| 10d |
Different materials in the primary packaging must be easy to separate |
No information |
| 11 |
Fitness for use: The product must be user friendly and comply with consumer needs. |
No information |
| 12a |
User instructions: Dosage instructions and the text (or equivalent text) “Proper dosage saves costs and
minimises environmental impacts” shall appear on the packaging |
Usually no information. May appear from technical information sheets |
| 12b |
Safety advice. The text: ”Keep away from children”, ”Do not mix different cleaners” as well as ”Avoid
inhaling sprayed product” for products packaged as sprays and the equivalent pictogram Do not inhale this
spray” for aerosol products |
The can be found or included in section 7. Classified products will be assigned
the corresponding S-phrase (S2, S50 and S23) and this will be stated in
section 15. Pictograms are not normally used |
| 12c |
Declaration of ingredients according to regulation (EC) No. 648/2004 |
May be stated in section 16 |
| 12d |
The following (or similar) text must appear on the packaging: “For more information visit the EU eco-label
web-site: http://europa.eu.int/ecolabel” |
No information |
| 13 |
Information appearing on the eco-label: Box 2 of the eco-label must contain the following text: “reduced
impact on aquatic life, reduced use of hazardous substances, clear user instruction” |
The eco-label is not usually reproduced in the safety data sheet |
| 14 |
Professional training: Offer for training |
No information |
As it appears from table 10, some of the information needed to apply for an eco label can be obtained from the safety data sheets, but the safety data sheet cannot be used in its present form as the sole
documentation when applying for an eco-label. However, it can be used to estimate whether an indoor paint or an all-purpose cleaner comply with the demands for assignment of the EU eco-label.
In this case, the safety data sheet must be supplemented with information on:
- Critical dilution volume of the product
- Biological degradability of surfactants
- Declaration
- of absence of certain substances – either that the product does not contain the substances or the concentration is below certain limits
- of production and handling of scents according to specific regulations
- of names of certain scents
- of content of volatile organic solvents
- that included dyes and colouring agents comply with the Directive on cosmetics or the regulation on colouring agents allowed in foodstuffs or should not be classified with the risk phrases R50/53 or
R51/53
7.4 Conclusions
The eco-label criteria operate with 3 criteria levels: ban, limitation and/or declaration demand while safety data sheets include demands for declaration of dangerous substances and safety advice for
protection of health and environment.
Essential for the elaboration of both eco-label application and safety data sheet is the complete chemical composition of the product – i.e. a split of the recipe at substance level.
If the full recipe (chemical names and percentages) is available at a substance level, it is possible to prepare both a safety data sheet and to examine whether the product is in compliance with the criteria for
absence of certain substances (e.g. substances that have been assigned certain R-phrases) and the criteria for the content being below a certain level. In addition, it would be possible to e.g. calculate
parameters as the critical dilution volume as set out in the criteria for universal cleaners and the combined content of phosphor and phosphonates in g/functional unit.
However, the down-stream user/manufacture seldom has full information on the chemical composition of the product but in most cases only the summarised information in the safety data sheet. Based on the
two examples above, it can be concluded that it is not possible to determine whether a product complies with the criteria for assignment of the eco-label on the basis of the information in the existing safety
data sheet alone. However it will be possible for the supplier (on request from the customer) to add relevant information to the SDS. It may also be more operational/understandable for the producer to
extend the information in the SDS instead of being requested to elaborate additional information in a format unknown to the producer.
When elaborating new eco-label criteria documents, guidance should be given on the information that may be requested by the supplier as part of the safety data sheet.
Environmental Product Declarations have the same fundamental need for data as eco-labels. As no limits are requested, EPD's should be able to take the relevant information directly from the SDS or
request the information in the form of an appropriate extended SDS.
A basic problem using the safety data sheet, as a provider of information through the product chain is that the quality is often very poor, even though it is stated in the safety data sheet directive that “the
safety data sheet should be prepared by a competent person”. This problem has also been acknowledged by the Commission in the directive 2001/58/EC [19] : “It is known from recent enforcement activities and studies in the Member States that many safety data sheets are of poor quality and do not provide adequate information for the user .” It is furthermore stated that one way to improve the quality
is to improve the guidance given to compilers and that the Commission and the Member states will consider other means by which the quality of safety data sheets can be improved in the future.”
It is the responsibility of the national authorities to ensure that the safety data sheets meet the requirements of the Safety Data Sheet Directive. However, the national authorities do not allocate the resources
necessary to check all safety data sheets, and therefore the control can only take place in the form of spot checks. The validity of SDS may presently therefore not be at the same level as third party verified
schemes.
The implementation of REACH may increase focus on the quality of the Safety Data Sheets. Furthermore REACH will contribute to the generation of the necessary information on the hazardous properties
of substances through the registration procedure.
The potential use of Safety Data Sheet information for other purposes than chemicals regulation and the need for appropriate co-ordination should as a minimum be explained in the new chemicals regulation
documents.
Footnotes
[8]
[9]http://europa.eu.int/comm/enterprise/reach/overview.htm
[10]Commission Decision of 3 September 2002 establishing revised ecological criteria for the award of the Community eco-label to indoor paints and varnishes and amending Decision 1999/19/EC
[11]CMR=Carcinogenic, mutagenic or toxic to reproduction
[12]Unless lower limits is given in Annex I to Directive 67/548/EEC or in Annexes II, III or IV to Directive 1999/45/EC
[13]www.europe.eu.int/comm/environment/ecolabel/pdf
[14]The functional unit is the dosage in grams of the produc recommended by the manufacturer for 1 litre of washing water.
[15]According the EU draft chemical regulation (REACH) the parameters PNEC (Predicted No-Effect Concentration) and DNEL (Derived No-Effect Level) shall be stated in section 8 of the SDS:
[16]According to the draft EU regulation on chemicals, it must be stated in the SDS if the product contains substances for which the use has to be authorised (CMR cat. 1 and 3, PBT- and vPvB substances
and other substances with serious irreversible effects (e.g. hormone disrupting chemicals).
[17]Council Directive 76/768/EEC and Council Directive 94/36/EC and subsequent amendments
[18]Directives 94/62/EC or DIN 6120, sections 1 and 2 in connection with DIN 7728, part1
[19]COMMISSION DIRECTIVE 2001/58/EC of 27 July 2001 amending for the second time the Directive 91/155/EEC
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