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Frequently asked questions



  • Chemical documentation
  • ADR
  • Biocides
  • Detergents

Which chemicals are classified as dangerous?

Dangerous chemicals are substances or mixtures with at least one dangerous characteristic. H-sentences (hazard statements) warn about the type danger.


According to the type of danger, dangerous chemicals can be classified in the following categories:
1. PHYSICAL HAZARDS:
  • Explosives
  • Flammable gases
  • Aerosols
  • Oxidizing gases
  • Gasses under pressure
  • Flammable liquids
  • Flammable solids
  • Self-reactive substances and mixtures
  • Pyrophoric liquids
  • Pyrophoric solids
  • Self-heating substances and mixtures
  • Substances and mixtures which, in contact with water, emit flammable gases
  • Oxidizing liquids
  • Oxidizing solids
  • Organic peroxides
  • Corrosive to metal

2. HEALTH HAZARDS
  • Acute toxicity
  • Skin corrosion/irritation
  • Serious eye damage/eye irritation
  • Respiratory or skin sensitization
  • Germ cell mutagenicity
  • Carcinogenicity
  • Reproductive toxicity
  • Specific target organ toxicity - single exposure (STOT SE)
  • Specific target organ toxicity - repeated exposure (STOT RE)
  • Aspiration hazard

3. ENVIRONMENTAL HAZARDS:
  • Acute toxicity for the aquatic ecosystem.
  • Chronic toxicity for the aquatic ecosystem.
  • Hazardous for the ozone layer.

How to recognize hazardous chemical?

Whether a chemical is hazardous or not, can be established in several ways:

  • on the packaging label and/or
  • in the Safety Data Sheet.

If there is at least an H-sentence or hazard pictogram on the label, the product is classified as dangerous.

In the Safety Data Sheet, the data about the hazard can be found in section 2.1. Currently, two systems of classifying and labelling chemicals are applicable. The old system (DPD) is based on the European directive from 1967 and 1999, and the new system (CLP) is based on the European Regulation No. 1272 from 2008.

Practically this means that different symbols, pictograms and texts can be used for the representation of danger. Since 1 December 2010, the new CLP system is exclusively used to label substances, while either the old or new system can be used to label mixtures (preparations). The transition period for labelling the mixture expires on 1 June 2017.

Hazardous chemicals are the one with at least one of the standard graphic symbols or pictograms on the label (packaging). In case of no symbol or pictogram, hazardous chemicals can be identified based on warnings or better known ‘R-sentences’ (DPD) or ‘H-sentences’ (CLP). They must be included on every packaging unit. According to the CLP regulation, besides H-sentences, also specific EUH-sentences can be used to mark the danger.

What is a Safety data sheet?

On the chemicals market, the Safety data sheet is an indispensable source of information. The Safety data sheet is a chemical’s identity card. It presents important information for people who come in contact with the dangerous chemical and for the healthcare personnel who take care of individuals in case of threatening health conditions dues to the harmful effects of the hazardous substances.

Which products require a Safety data sheet?

A Safety data sheet has to be prepared for all chemicals classified as dangerous.

The substance or mixture supplier must provide a Safety data sheet to the recipient of the substance or mixture, and the sheet must be filled out in accordance with Annex II of the REACH Regulation in cases:
  • when a substance or mixture meets the criteria for classification as hazardous in compliance with the Regulation (EC) No 1272/2008 or
  • when the substance is persistent, builds up in organisms and is toxic or very persistent and can build up in organisms in accordance with the criteria from Annex XIII; or
  • when the substance is included in the list drawn up in accordance with Article 59(1) of the REACH Regulation for different reasons than those in points (a) and (b).

The recipient can claim the Safety data sheet from the supplier also when a substance or mixture does not meet the criteria for classification as hazardous in compliance with Regulation (EC) No. 1272/2008, but includes:
  • in an individual concentration ≥ 1 mas. % for non-gas mixtures and ≥ 0.2 vol. % for gas mixtures at least one substance hazardous to human health or the environment, or
  • in an individual concentration ≥ 1 mas. % for non-gas mixtures at least one substance which is carcinogenic from category 2, toxic to reproduction from categories 1A, 1B and 2, causes skin sensitization from category 1, causes respiratory sensitization from category 1 or effects lactation or breast milk or is persistent, may build up in organisms and is toxic (PBT) in compliance with criteria from Annex XIII or is very persistent and can build up in organisms (vPvB) in accordance with criteria from Annex XIII or is included in the list drawn up based on Article 59(1) from different reasons than those in point (a), or
  • a substance for which workplace exposure limits at the Community level exist.

The supplier must in this case provide a Safety data sheet to the recipient on his or her request, and the sheet must be filled out in accordance with Annex II of the REACH Regulation in cases:

The Safety data sheet does not need to be provided if the hazardous substances or mixtures which are offered or sold to the public have enough information (e.g. label) which enables users to adopt all necessary measures to protect human health, safety and the environment, unless requested by the further user or distributor.

In which language must the Safety data sheet be written?

The Safety data sheet must be available in the official language of the state in which the hazardous chemical is marketed.

Translations of Safety data sheets for hazardous chemicals are not obligatory. They are, however, recommended. In most EU countries, companies demand Safety data sheets in the Slovene language, regardless of the hazard. Translations of Safety data sheets are also obligatory in most calls for tenders.

What are the reasons for changing the Safety data sheet?

In reality, a good safety data sheet is no older than two years. The Safety data sheet must be regularly revised or changed and supplemented.

Reasons for changing a Safety data sheet may be:

  • changes in the legislation which stipulates the content and form of a Safety data sheet,
  • recipe changes (new composition) which can lead to a different product classification,
  • changes in the classification of individual substances in the product which can lead to a different product classification,
  • new discoveries about handling the dangerous substance,
  • new results from animal tests and in an aquatic environment (toxicological and ecological data),
  • new workplace exposure limits,
  • new definition of the proper protective equipment,
  • ADR novelties (dangerous goods transport).

In what way the content and form of the Safety data sheet are established?

The content and form of the Safety data sheet are specifically provided by the European Regulation No. 830/2015.

A Safety data sheet is composed of 16 sections:

  • Identification of the substance/mixture and company/entity
  • Hazard determination
  • Composition/data on the ingredients
  • First aid measures
  • Firefighting measures
  • Measures in case of unintentional emissions
  • Handling and storage
  • Exposure control/personal protection
  • Physical and chemical properties
  • Stability and reactivity
  • Toxicological information
  • Ecological information
  • Disposal
  • Transportation data
  • Data on statutory requirements
  • Other information

How are the Safety data sheet and label related?

Label elements are stipulated in item 2 of the Safety data sheet. In practice, there are often discrepancies between the label and the Safety data sheet. The most common errors are:

  • the marketing name on the Safety data sheet does not match the marketing name on the label,
  • the safety data sheet contains different H and P sentences than the label,
  • the label does not state any additional warnings (e.g. for aerosols, isocyanides etc.).

What is the purpose of marking the chemicals?

In accordance with the chemicals provisions, the basic purpose of marking or labels is to inform the user (consumer) about the dangers of the chemicals. The label is therefore the key element that makes first contact with the user of the chemical. That is why each hazardous chemical must be properly marked with a label. The sale of incorrectly or improperly marked hazardous chemicals is a violation.

Which are the basic label elements?

Currently, there are two applicable marking systems: the old (DPD) system, which can be used until 1 June 2017, and the new (CLP) system.


Label elements:
  • Trade name of the product
  • Danger symbols or pictograms (if required)
  • Symbol name – in old (DPD) labels
  • Warning sentences (R-sentences) or hazard statements (H-sentences)
  • Notification sentences (S-sentences) or precautionary statements (P-sentences)
  • Warning word “DANGER” or “ATTENTION” – only on new CLP labels
  • Net quantity
  • Name, address and phone number of the supplier

Which can be additional label elements?

  • Warning for aerosols, sign "3"
  • Special detergent labelling
  • Additional information for a biocidal product
  • Volatile organic compound content (HOS – Category and Limit Value)
  • Dangerous substances statement
  • Warning: the product contains substances which can cause allergic reactions.
  • Warning: the product contains special dangerous substances (e.g. isocyanates, MDI, epoxides, lead, cyanoacrylate, chromium (IV), cadmium etc.).
  • Warning: dangerous substances can be emitted during use (e.g. chlorine).
  • Warning for liquid waxes which are harmful to health if swallowed.
Example of an old (DPD) label:

Trade name

1 l

Contains:2-butanone oxime.

Warning:R11 Highly flammable. R36 Irritating to eyes. R43 May cause sensitisation by skin contact. R66 Repeated exposure may cause skin dryness or cracking. R67 Vapours may cause drowsiness and dizziness.

S16 Keep away from sources of ignition - No smoking. S2 Keep out of the reach of children. S24/25 Avoid contact with skin and eyes. S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S33 Take precautionary measures against static discharges. S36/37/39 Wear suitable protective clothing, gloves and eye/face protection.

Supplier: BENS consulting d.o.o., Groharjeva 16, 1241 Kamnik, Slovenija

Tel:+386 1 562 19 20

Lahko vnetljivo Highly flammable
Dražilno Irritant

Example of a new (CLP) label:

Trade name

1 l

Danger:H225 Highly flammable liquid and vapour. H317 May cause an allergic skin reaction. H319 Causes serious eye irritation. H336 May cause drowsiness or dizziness. EUH066 Repeated exposure may cause skin dryness or cracking.

P102 Keep out of reach of children. P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. P403 + P233 Store in a well-ventilated place. Keep container tightly closed. P501 Dispose of contents/container in accordance with local regulation.

Supplier: BENS consulting d.o.o., Groharjeva 16, 1241 Kamnik, Slovenija

Tel:+386 1 562 19 20


Example of a multilingual label – statements must be the same in all languages (same H and P-sentences).

Trade name

1 l

EN: Contains: ethyl acetate; 2-butanone oxime.
Danger: H225 Highly flammable liquid and vapour. H317 May cause an allergic skin reaction. H319 Causes serious eye irritation. H336 May cause drowsiness or dizziness. EUH066 Repeated exposure may cause skin dryness or cracking.
P102 Keep out of reach of children. P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. P403 + P233 Store in a well-ventilated place. Keep container tightly closed. P501 Dispose of contents/container in accordance with local regulation.

DE: Enthält: ethylacetat; 2-Butanonoxim.
Gefahr: H225 Flüssigkeit und Dampf leicht entzündbar. H317 Kann allergische Hautreaktionen verursachen. H319 Verursacht schwere Augenreizung. H336 Kann Schläfrigkeit und Benommenheit verursachen. EUH066 Wiederholter Kontakt kann zu spröder oder rissiger Haut führen.
P102 Darf nicht in die Hände von Kindern gelangen. P210 Von Hitze, heißen Oberflächen, Funken, offenen Flammen sowie anderen Zünd­quellenarten fernhalten. Nicht rauchen. P305 + P351 + P338 BEI KONTAKT MIT DEN AUGEN: Einige Minuten lang behutsam mit Wasser spülen. Vorhandene Kontaktlinsen nach Möglichkeit entfernen. Weiter spülen. P333 + P313 Bei Hautreizung oder -ausschlag: Ärztlichen Rat einholen/ärztliche Hilfe hinzuziehen. P403 + P233 Behälter dicht verschlossen an einem gut belüfteten Ort aufbewahren. P501 Inhalt/Behälter gemäß lokalen/regionalen/nationalen Vorschriften zuführen.

Supplier / Lieferant / BENS consulting d.o.o., Groharjeva 16, 1241 Kamnik, Slovenija
Tel: +386 1 562 19 20

What must be considered in advertising and internet selling of chemicals?

When advertising a substance, the following elements must be included in the ad:

  • danger class and/or
  • danger category

Statement example: acute oral toxicity, category 3

When advertising a mixture, the following elements must be included in the ad:

  • danger pictogram
  • warning text
  • hazard statements (H-sentences, EUH-sentences)

The ad must contain all the above-mentioned elements. P-sentences do not need to be stated.

Example of an ad for an irritant chemical:

DANGER
H319 Causes serious eye irritation.

Should the tactile warning be placed on the inner or outer packaging?

The technical requirements for tactile warnings are stated in the EN ISO 11683 standard. It requires the tactile warning to be placed on the primary/inner packaging.

Which products must have a tactile warning and safe lock?

Tactile warning and a safe lock must be placed on products for public (general use), namely regarding the type of danger. This does not apply to aerosols, marked with H222 or H223.

Which types of danger symbols do we know?

Symbols, marking dangerous physical characteristics:

E

Explosive

O

Oxidizing

F+

Extremely Flammable

F

Flammable

Symbols, marking characteristics hazardous to health:

T+

Very toxic

T

Toxic

C

Corrosive

Xn

Harmful

Xi

Irritant

Symbols, marking characteristics hazardous to the environment:

N

Dangerous for the environment

Which dangers are marked by pictograms?

Pictograms, marking dangerous physical characteristics:

Pictogram

Danger

  • Unstable explosives
  • Self reactive substances and mixtures
  • Organic peroxides
  • Flammable gases
  • Aerosols
  • Flammable liquids
  • Flammable solids
  • Self-reactive substances and mixtures
  • Pyrophoric liquids
  • Pyrophoric solids
  • Self-heating substances and mixtures
  • Substances and mixtures, which in contact with water, emit flammable gases
  • Organic peroxides
  • Oxidising gases
  • Oxidising liquids
  • Oxidising solids

    Gases under pressure:

  • Compressed gases;
  • Liquefied gases;
  • Refrigerated liquefied gases;
  • Dissolved gases
  • Corrosive to metals

Pictograms, marking characteristics hazardous to health:

Pictogram

Danger

  • Acute toxicity (oral, dermal, inhalation)
  • Skin corrosion
  • Serious eye damage
  • Acute toxicity (oral, dermal, inhalation)
  • Skin irritation
  • Eye irritation
  • Skin sensitisation
  • Specific Target Organ Toxicity — Single exposure
  • Respiratory tract irritation
  • Narcotic effects
  • Respiratory sensitisation
  • Germ cell mutagenicity
  • Carcinogenicity
  • Reproductive toxicity,
  • Specific Target Organ Toxicity — Single exposure
  • Specific Target Organ Toxicity — Repeated exposure
  • Aspiration hazard

Pictograms, marking characteristics hazardous to the environment:

Pictogram

Danger

    Hazardous to the aquatic environment

  • Acute hazard category
  • Long-term hazard categories
  • Hazardous to the ozone layer

What ADR means?

The acronym ADR is derived from the European Agreement Concerning the International Carriage of Dangerous Goods by Road.

ADR is to be used in all countries that signed this Agreement. Goods are classified as dangerous for transport if they are granted an UN number. Transport data (e.g. UN number, danger label, package group etc.) are listed in item 14 of the safety data sheet.

What does the transport of dangerous goods per exemptions mean?

  • Dangerous goods packed in limited quantities (small packaging units), section 3.4 ADR
  • Exemptions related to quantities per transport unit, section 1.1.3.6 ADR

When is a product classified as dangerous goods in the sense of transport regulations?

Transport information can be found under item 14 of the safety data sheet. Dangerous goods have a certain UN number (e.g. a dye with a flashpoint under 60°C is allocated under UN 1263). Besides the UN number, other transport data are listed under item 14 required to properly mark the packaging and prepare the relevant transport documentation.

Is ADR transport required to dispatch 1 carton of dye packed in 2.5 L packaging with a flashpoint 56°C?

According to the ADR, dye is classified as dangerous goods with UN 1263. Since it has a flashpoint of 56°C, it is classified under the packaging group III. This UN number has a limited quantity of 5 L (column 7a in Table 3.2 ADR). Since the dye is packed in a packaging containing less than 5 L, exemptions can be used which can be found in section 3.4 of the ADR. It is important to put a danger label for limited quantities (LQ) on the carton and that the gross volume does not exceed 30kg. ADR transport is thus not needed to dispatch.

LQ Label:

LQ Label

How to calculate points according to the section 1.1.3.6 of ADR?

We would like to transport:

  • 5 handles of each 10 L dye with No. UN 1263, transport group 3 (the quantity must be multiplied by the factor 1)
  • 4 handles of each 20 L solvent with No. UN 1993, transport group 2 (quantity must be multiplied by the factor 3)

Calculation: 5×10×1 + 4×20×3 = 290

Since the number of points is lower than 1000, an exemption can used to transport smaller quantities of dangerous goods and ADR transport is not required.

Example of written instructions for action in case of an accident (link)

What are biocidal products?

A biocidal product is any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

The criteria to be classified as a biocidal product are two:

  • The product must contain an active substance approved for one or more biocidal purposes. The active substance has a controlling effect on harmful organisms with biological or chemical action.
  • The product must actually be used for a certain purpose, e.g. for destroying bacteria, and as a repellent to mosquitoes. The content of a label on biocidal products is essential. Only one word can make a difference.

Which types of biocidal products do we know?

We know 22 different types of biocidal products. The most common biocidal products are:

  • Insecticides: products for destroying flies, mosquitoes and other insects;
  • Preservatives: chemicals used as preservatives in products and materials (e.g. colours and varnishes, detergents, fabric softeners etc.)
  • Disinfectants: cleaning and similar products used for disinfecting surfaces, materials and equipment, and products for disinfecting the skin and similar products for human hygiene;
  • Attractants, repellents: products used for the repulsion or attraction of harmful organisms (e.g. insects).

Which documents are used for the traceability of active substances?

Statement forms about the delivery confirmation which shall be used by the companies from the list in Article 95 of BPR:

Statement forms for companies placing biocidal products on the market:

Which are the procedures after placing the active substance on the list of approved active substances of the EU?

  1. National authorization
    National authorization is an administrative act by which the competent authority of a Member State authorizes the making available on the market and the use of a biocidal product or a biocidal product family in its territory or in a part thereof.
  2. Mutual recognition in sequence
    Sequential mutual recognition of a national authorization for a biocidal product is a procedure under which an applicant applies for the authorization of a biocidal product in one or more Member States once the authorization for this biocidal product has been granted in one Member State in accordance with Article 17 of Regulation (EU) No. 528/2012.
  3. Mutual recognition in parallel
    Parallel mutual recognition of a national authorization for a biocidal product is a procedure under which an applicant applies for the authorization for a biocidal product and the authorization for this biocidal product has not yet been granted in accordance with Article 17 of Regulation (EU) No. 528/2012.
  4. Authorization for equal biocidal products
    The authorization for an equal biocidal product or family of products is granted for equal/identical products of the same or different company under the same provisions and conditions of an already granted authorization.
  5. Parallel marketing
    Authorization for parallel marketing is granted in a member state for a biocidal product for which an authorization has already been granted in another Member State (country of origin) and is identical to the product with an authorization in another Member State (reference product).

    Identity requirements:

    • the products are made by the same company, by an associated company or were made based on the licence according to the same production procedure;
    • the products are identical in their specifications and content, active substances and type of formulation;
    • the products are identical regarding the content of their inactive substances;
    • the products are identical or equivalent regarding their size, material or packaging shape in the sense of an unwanted effect on the product safety, human health, animal health or environment.
  6. Union authorization
    Union authorization is an administrative act by which the European Commission authorizes the making available on the market and the use of a biocidal product or a biocidal product family in the EU territory or in a part thereof.
  7. Simplified procedure

    Authorization based on a simplified procedure can be issued for biocidal products which meet the following conditions:

    • all active substances in the biocidal product are on the list from Annex II of Regulation (EU) No. 528/2012 and meet all conditions from the Annex;
    • the biocidal product does not contain any harmful substances;
    • the biocidal product does not contain any nanomaterials;
    • the biocidal product is effective enough;
    • no personal protective equipment is required for handling and using the biocidal product.

How can biocidal products be advertised?

Only biocidal products with a proper marketing authorization can be advertised, recommended or advised.

In case of advertising biocidal products, each advertisement must contain the following text:

"Use biocides safely. Always read the label and product information before use." The sentences shall be clearly distinguishable in relation to the whole advertisement.

Advertisers may replace the word "Biocides" in the prescribed sentences with an accurate description of the product-type being advertised.

Advertisements for biocidal products may not refer to the product in a manner which is misleading in respect of the risks from the product to man, animals, the environment or its effects.

Under no circumstances may the advertising of a biocidal product mention "low-risk biocidal product", "non-toxic", "harmless", "natural", "environmentally-friendly", "animal-friendly" or any similar indications.

What are treated products?

A "Treated product" is any substance, mixture or product which was treated with one or more biocidal products or contains them intentionally. A treated product with a biocidal function as primary is considered as a biocidal product.

A treated product may not be placed on the market unless all the active substances in the biocidal product which are used for the treatment of the product or are contained in the treated product, are on the list of approved active substances for this type of product and supplied by suppliers from the list in Article 95 of BPR.

The person responsible for placing the treated product on the market shall make sure the label includes:

  • a statement that the treated product contains biocidal products;
  • a justified biocidal characteristic of the treated product;
  • the names of all the active substances contained in the biocidal products without breaking Article 24 of the Regulation (EC) No. 1272/2008 (CLP);
  • names of all the nanomaterials contained in the biocidal products which have the word ‘nano’ written in brackets after the main word;
  • all relevant instructions for use, including all precautionary measures, which must be adopted due to the biocidal products used to treat the treated product or contained in the treated product.

What are detergents?

A detergent is any substance or preparation which contains soap and/or other surfactants for washing and cleaning procedures. Detergents can be in any kind of form (liquid, powder, paste, stick, cake, molded or shaped piece etc.) and can be put on the market or used in households, institutions or industry.

Which types of detergents do we know?

  • Detergents for hand and machine dish washing
  • Detergents for washing clothes (washing powders, gels)
  • Auxiliary washing preparations for soaking (pre-washing), rinsing or whitening clothes
  • Fabric softeners for changing the feel of fabric in procedures which supplement washing of clothes
  • Cleaning preparations for universal household cleaning products and/or other types of surface cleaning (e.g. materials, products, machines, hardware, transportation means and all associated equipment, instruments, appliances)

When can a detergent be put on the market?

If a detergent is classified as dangerous, regulations relating to the market of dangerous chemicals must be considered primarily (acquiring marketing authorization for dangerous chemicals, making of a safety data sheet, label, applying to the Chemicals Office or acquiring an authorization number, reporting annual volumes etc).

All detergents (dangerous and non-dangerous) must be correctly marked. If the concentration of ingredients from the list in Annex VII of the Regulation (EC) No. 648/2004 exceeds 0.2%, they have to be stated on the packages of detergents intended for general use.

The content of enzymes, optical brighteners, fragrances and disinfection ingredients should be stated regardless of their concentration.

Special rules also apply to stating allergenic fragrances classified in Annex III of the Regulation (EC) 1223/2009 on cosmetic products. They always have to be stated on the outer packaging with the actual names from the Regulation on cosmetic products when their concentration in the product exceeds 0.01%.

Surfactants must meet the requirements about biodegradability of surfactants within the meaning of the Regulation (EC) No. 648/2004 on detergents.

Conditions for the use of phosphates in other phosphoric compounds in household detergents for washing clothes and machine washing of dishes.

Is there any additional labelling of detergents?

So called A.I.S.E symbols, icons for the safe use of detergents stated on the packaging can be helpful to consumers. This information is optional and enables the correct use of detergents. Nonetheless, guidelines and instructions by the A.I.S.E. – International Association for Soaps, Detergents and Maintenance should be followed.

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