Safety data sheet

conforms to Regulation (EC) No. 1907/2006, Article 31

Lactose, Eur. Ph.- USP/NF - JP

Date of issue: 03.07.2013
Date of revision: 01.03.2017

1 Identification of the substance / preparation and oft the company / undertaking

Product name: Lactose Eur. Ph.-USP/NF – JP

O-ß-D-Galactopyranosyl-(1-4)-α-D-glucopyranose
monohydrate

Product use: Lactose Eur. Ph.-USP/NF – JP is used in pharma industries,

used as an ingredient in infant formulas, follow-on formulas
and as food ingredient in a food industry

CAS-Registry Number: 10039-26-6

Manufacturer/Distributor: ALPAVIT Käserei Champignon Hofmeister GmbH & Co. KG

Kemptener Straße 17 – 24
87493 Lauben
Germany

Tel.: +49 (0) 8374 92 320

Fax: +49 (0) 8374 92 321
E-Mail: info@alpavit.de

2 Hazards identification

Dust explosion: If there is an insufficient explosion protection

Classification according to
Directive 67/548/EEC or
Directive 1999/45/EC: not applicable

3 Composition / information on ingredients

Components: According Eur. Ph.-USP/NF – JP for lactose

Safety data sheet
conforms to Regulation (EC) No. 1907/2006, Article 31

Lactose, Eur. Ph.- USP/NF - JP

Date of issue: 03.07.2013
Date of revision: 01.03.2017

4 First aid measures

Note to physician: Immediate medical attention is not necessary

General information: No special measures required
Inhalation: Remove victim to fresh air
Skin contact: Rinse with running water
Eye contact: Immediately flush eyes with plenty of water, occasionally
lifting the upper and lower eyelids. Continue to rinse a few
minutes.

Ingestion: Not relevant, because suitable for consumption, otherwise,

drink plenty of water

5 Firefighting measures

Suitable extinguishing media: With water, CO2, or foam

Special protective equipment: Wear protective device exhaled air

6 Accidental release measures

Personal precautions: Not required

Environmental precautions: No special measures required
Methods for cleaning up: Mechanically or with dust exhauster

7 Handling and storage

Precautions for safe handling: No special measures required

Notes for protection fire-
and flame trap: Avoid open flames because of possible dust explosion

Storage: In closed package, dry, clean and protected from light and
off flavours, storage conditions:
>10 °C < 45 °C, and max. 65% rel. humidity

Advice on Storage: Do not store with oxidizing chemicals

Safety data sheet
conforms to Regulation (EC) No. 1907/2006, Article 31

Lactose, Eur. Ph.- USP/NF - JP

Date of issue: 03.07.2013
Date of revision: 01.03.2017

8 Exposure controls / personal protection

Technical measures: exhaust system for avoidance of dust development

recommended

Personal protection: Respiratory protection recommended for dust

development during emptying

Occupational exposure limits: Not applicable

Other protection: Handle in accordance with good industrial hygiene and

safety practice

9 Physical and chemical properties

Physical state: Crystalline powder

Color: White
Odour: Pure, without off-smell
Taste: Sweet
Max. explosion over pressure: 7,2 bar [pmax]
Max. rate of pressure rise: 81 bar * m/s [Kst-Value]
Lower explosive limit: 60 g/m³
Minimum ignition energy: > 10 mJ
Ignition temperature: 450 °C
Glowing temperature: 420 °C
Combustibility: 2
Median value: 160 – 180 µm (depending on granulation)
Bulk weight: 590 – 870 g/L (depending on granulation)
Solubility: water solubility

10 Stability and reactivity

Preventive measure: Close open packaging

Hazardous decomposition products: No hazardous decomposition products know
Possibility of hazardous reactions: No hazardous reactions know
Safety data sheet
conforms to Regulation (EC) No. 1907/2006, Article 31

Lactose, Eur. Ph.- USP/NF - JP

Date of issue: 03.07.2013
Date of revision: 01.03.2017

11 Toxicological information

Acute toxicity: As food, therefore non-toxic

General notes: With proper handling and intended use of the product no
dangerous-to-health effects know

12 Ecological information

Eco toxicity: No relevant information available

General notes: Bio-degradable

13 Disposal consideration

Method of waste treatment: Smaller quantities can be disposed with household waste

Contaminated packaging: Contaminated packaging must be disposed according to the

official regulation

14 Transport information

International regulation: Not relevant, no dangerous good

15 Regulatory information

Chemical safety assessment: Chemical safety assessment was performed

16 Other information

Reach-Regulation: Conforms to Regulation (EC) No. 1907/2006, Article 2 is

Lactose Eur. Ph.-USP/NF – JP exempt from the regulation
obligation

General notes: This information is based upon our today’s knowledge. The
statement describes our product in view of safety
requirements and does not have the meaning to guarantee
certain characteristics. The details given here are intended
merely for information purposes and are in no way legally
binding.