Registration Dossier

Administrative data

First-aid measures

Description of first aid measures
Inhalation

Effects: May cause allergic respiratory reaction.
Symptoms: Shortness of breath, wheezing and coughing. The effect of inhalation may be delayed.
First Aid: Remove person to fresh air. If signs/symptoms continue, get medical attention. Show the safety data sheet to the doctor in attendance.

Skin contact
Effects: May cause slight irritation.
Symptoms: Slight irritation.
First Aid: Remove and wash contaminated clothing before re-use. Wash off immediately with plenty of water. If symptoms persist, call a doctor. Show the safety data sheet to the doctor in attendance.

Eye contact
Effects: May cause slight irritation.
Symptoms: Slight irritation.
First Aid: Hold eye open and rinse slowly and gently with water for 15-20 min. Remove contact lenses, if present, after the first five minutes, then continue rinsing the eye. If symptoms persist, call a doctor. Show the safety data sheet to the doctor in attendance.

Ingestion
Effects: Ingestion may cause gastro-intestinal irritation.
Symptoms: Irritation.
First Aid: Rinse mouth with water and drink plenty of water. If symptoms persist, call a doctor. Show the safety data sheet to the doctor in attendance.

Fire-fighting measures

Suitable extinguishing media:
Standard procedure for chemical fires; foam, water spray, dry chemical or carbon dioxide.

Hazardous combustion products:
On burning, this material may generate toxic gases of combustion such as oxides of carbon, nitrogen and sulphur (COx, NOx and SOx) just like any organic material.

Specific hazards arising from the chemical:
May cause an allergic respiratory reaction.

Protective equipment and precautions for fire fighters:
As in any fire, wear self-contained breathing apparatus and full protective gear.

Accidental release measures

Personal precautions
Wear suitable personal protection.

Respiratory Protection:
Maintain adequate ventilation. When workers are facing concentrations above the exposure limit they must use appropriate certified respirators. Respirator with a particle filter (EN 143). P3 filters are recommended.

Eye protection:
Safety glasses with side-shields. Avoid contact with eyes.

Skin Protection:
Wear protective gloves/clothing.

Hand Protection:
Use protective gloves that meet the minimum requirements of EN420 w hen handling solid products. Gloves that meet the additional requirements of EN374-2 should be worn when handling of liquid products. Practical experience has shown that nitrile rubber, butyl rubber, natural rubber (latex) and polyvinyl chloride (PVC) gloves offer adequate protection. There is no additional material, thickness, or breakthrough time requirements. Chemical resistant gloves, as defined according to EN374-3 are not required.

Environmental precautions
Prevent the material from entering surface water or sanitary sewer system. Do not discharge directly to a water source. If accidental spillage or w ashings enter drains or watercourses contact the local Environmental Authorities

Methods for cleaning up
Use appropriate personal protection. Avoid contact with the product. Contain spilled product. Collect spilled material by non-dispersive methods or with a vacuum cleaner equipped with a high efficiency filter. After spillage avoid generating aerosols or dust from dried preparation. Do not sweep, brush, use compressed air, which can create aerosols. Avoid splashing and high pressure washing. Provide for sufficient ventilation. Wash with plenty of water.

Handling and storage

Handling
Handle in accordance with good industrial hygiene and safety practice. Avoid contact with skin, eyes and clothing.

Wear suitable gloves and eye/face protection. Ensure adequate ventilation. Avoid formation of dust and aerosols.

Provide appropriate exhaust ventilation at places w here dust is formed. Avoid accumulation of dust.

Avoid breathing dust or spray mist. Conduct regular cleaning of equipment, work area and clothing.

Storage
Keep container tightly closed in a cool, dry and w ell-ventilated place. Temperature 0-25°C (32°F-77° F).
Storage conditions: In unbroken packaging - dry and protected from the sun.

Transport information

Land transport (ADR/RID)

UN number:
Not regulated as dangerous goods according to transport regulations (ADR/RID).
Shippingopen allclose all
Class:
Not regulated as dangerous goods according to transport regulations (ADR/RID).
Classification code:
Not regulated as dangerous goods according to transport regulations (ADR/RID).
Packaging group:
Not regulated as dangerous goods according to transport regulations (ADR/RID).
Labels:
Not regulated as dangerous goods according to transport regulations (ADR/RID).
SpecialProvisionsopen allclose all

Inland waterway transport (ADN(R))

UN number:
Not regulated as dangerous goods according to transport regulations.
Shippingopen allclose all
Class:
Not regulated as dangerous goods according to transport regulations.
Classification code:
Not regulated as dangerous goods according to transport regulations.
Packaging group:
Not regulated as dangerous goods according to transport regulations.
Labels:
Not regulated as dangerous goods according to transport regulations.
Remarksopen allclose all

Marine transport (IMDG)

UN number:
Not regulated as dangerous goods according to transport regulations (IMDG).
Proper shipping name and description:
Not regulated as dangerous goods according to transport regulations (IMDG).
Chemical name:
Not regulated as dangerous goods according to transport regulations (IMDG).
Class:
Not regulated as dangerous goods according to transport regulations (IMDG).
Packaging group:
Not regulated as dangerous goods according to transport regulations (IMDG).
EmS code:
Not regulated as dangerous goods according to transport regulations (IMDG).
Labels:
Not regulated as dangerous goods according to transport regulations (IMDG).
Remarksopen allclose all

Air transport ICAO/IATA

UN number:
Not regulated as dangerous goods according to transport regulations (ICAO/IATA).
Proper shipping name and description:
Not regulated as dangerous goods according to transport regulations (ICAO/IATA).
Chemical name:
Not regulated as dangerous goods according to transport regulations (ICAO/IATA).
Class:
Not regulated as dangerous goods according to transport regulations (ICAO/IATA).
Packaging group:
Not regulated as dangerous goods according to transport regulations (ICAO/IATA).
Labels:
Not regulated as dangerous goods according to transport regulations (ICAO/IATA).
Remarksopen allclose all
SpecialProvisionsopen allclose all

Exposure controls / personal protection

Eye/face protection:
- Tight-fitting protective goggles with side protection (EN 166).

Skin protection – hand protection:
- Rubber gloves (EN374).
- Protective hand-cream recommended.

Skin protection – Other:
- Protective working garments (e.g. safety shoes EN ISO 20345, long-sleeved protective working garments).

Respiratory protection:
- If OES or MEL is exceeded:
- Breathing mask with fine-dust filter (EN143), colour code white.
- Filter P3, FFP3 (EN 143).
- Observe wearing time limitations for respiratory protection equipment.

Thermal hazards:
- Not applicable.
Additional information on hand protection – No tests have been performed.
- In the case of mixtures, the selection has been made according to the knowledge available and the information about the contents. The selection of materials has been derived from the glove manufacturers indications.
- Fine selection of glove material must be made taking the breakthrough times, permeation rates and degradation into account.
- Selection of a suitable glove depends not only on the material, but also on other quality characteristics, and varies from manufacturer to manufacturer.
- In the case of mixtures, the resistance of glove materials cannot be predicted and must therefore be tested before use.
- The exact breakthrough time of the glove material can be requested from the protective glove manufacturer and must be observed.

Environmental controls:
- No information available at present.

Due to the intrinsic hazard for respiratory sensitization which is associated to enzymes, the industry and its trade associations have over the years developed and updated several guidelines on the safe industrial handling of enzyme products, and guidelines on the development of safe enzyme containing consumer products. Workshops on these issues have also been arranged by the trade associations in order to convey product stewardship and to ensure correct risk management. Examples of such guidelines are shown below:

• Amfep, 2013. Association of Manufacturers of Fermentation Enzyme Products. October 2013; “Guide to the safe handling of industrial enzyme preparations”. 12 pages. Brussels http://w w w .amfep.org/content/safe-handling-guide-2013 First edition published in 2001.

• AISE, 2013. The international Association for Soaps, Detergents and Maintenance Products. September 2013; “Guiding principles for the safe handling of enzymes in detergent manufacture”. 122 pages . Brussels w w w .aisenet.org First edition published in 2002.

• AISE, 2013. The international Association for Soaps, Detergents and Maintenance Products. September 2013; “Exposure measurements of enzymes for risk assessment of household cleaning spray products”. Brussels http://w w w .aise.eu/publications.php?cat=A.I.S.E. First edition published in 2010.

• Novozymes A/S, 2012. Poster illustrating safe handling of granulated enzyme products, and poster illustrating safe handling of liquid enzyme products. Available from Novozymes customer site. First edition published in 2001

• Novozymes A/S, 2011. “Enzymes and You”. Bagsvaerd DK. 51 pages. Available from Novozymes customer site. First edition published in 1992

• Novozymes A/S, 2007. “Safe handling of enzymes”. Bagsvaerd DK. 38 pages. Available from Novozymes customer site. First edition published in 1992

• AISE, 2006. The international Association for Soaps, Detergents and Maintenance Products. 2006; “Developing consumer products containing enzymes: Ensuring consumer safety”. Brussels w w w .aise-net.org

• Amfep, 2006. Association of Manufacturers of Fermentation Enzyme Products. February 2006; “Amfep and ETA position on consumer risk assessments for enzyme-containing personal care products and cosmetics”. Brussels http://amfep.drupalgardens.com/sites/amfep.drupalgardens.com/files/Amfep-ETA-position-Cosmetics.pdf#overlaycontext=content/documents. First edition published in 1999

• US SDA, 2005. The Soap and Detergent Association (SDA). Risk Assessment Guidance for Enzyme-containing Products. US Soap and Detergent Association, Washington, DC. 58 pages. http://w w w .cleaninginstitute.org/science/enzyme_safety.aspx

• US SDA, 1995. The Soap and Detergent Association (SDA). “Work practices for handling enzymes in the detergent industry”. New York: The Soap and Detergent Association. 55 pages. http://w w w .cleaninginstitute.org/science/enzyme_safety.aspx

• SDIA 1991. The Soap and Detergent Industry Association (merged into AISE in 1999 ?) “The Standing Committee on Enzymatic Washing Products, Revised Operating Guidelines, Fifth Report”. London. First edition published in 1969

• SDIA 1971. The Soap and Detergent Industry Association (merged into AISE in 1999 ?) “Recommended Operating Procedures for UK Factories Handling Enzyme Materials”. London. The Annals of Occupational Hygiene, June 1971, Vol 14 Issue: 2 p71-83.

Stability and reactivity

Reactivity:
- The product has not been tested.

Chemical stability:
- Stable with proper storage and handling.

Possibility of hazardous reactions:
- No dangerous reactions are known.

Conditions to avoid:
- See also Handling and storage section.
- Protect from humidity, heating, open flame, ignition sources and electrostatic charge.

Incompatible materials:
- Avoid contact with other chemicals.
- Avoid contact with oxidizing agents.
- Avoid contact with strong alkalis.
- Avoid contact with strong acids.

Hazardous decomposition products:
- See also section “Fire-fighting measures – Special hazards arising from the substance or mixture”
- No decomposition when used as directed.

Disposal considerations

Waste treatment methods for the substance / mixture / residual amounts:

EC disposal code number:
- The waste codes are recommendations based on the scheduled use of this product.
- Owing to the user’s specific conditions for use and disposal, other waste codes may be allocated under certain circumstances (2001/118/EC, 2001/119/EC, 2001/573/EC). 04 02 99 wastes not otherwise specified.
- Recommendation: pay attention to local and national official regulations eg. Suitable incineration
plant.

For contaminated packing material:
- Pay attention to local and national official regulations.
- Recommendation: Suitable incineration plant. Cleaned packaging. Recycling.
- 15 01 01 paper and cardboard packaging.
- 15 01 02 plastic packaging.