FDA approved as a food additive

ACS 100 Kosher Food Additive Acidulant comprised of GRAS (Generally Recognized As Safe) food grade ingredients therefore legislatively allowed in food.

Click here for the USDA Labeling and Consumer Protection Staff website.

Click here for a direct link to the listing of "acidic calcium sulfate" at the USDA LCPS site. Choose your desired version of Amendment 1 - Change Transmittal Sheet

1.    11-9-01 - FDA "no objection" to use ACS in food.

2.    10-3-02 - There appears to be no issues involving the safety of seafood products treated with ACS 100 Kosher Food Additive Acidulant^®.

3.    1-20-04 - FDA "no objection" to the use of the term "acidic calcium sulfate" for labeling purposes.

USDA/FSIS Approvals & Clarifications

1.    3-12-02 - Letter from FSIS clarifying that when FDA used the term "food" in the letter of 11-9-01, FDA did intend to include meat and poultry products as "food". "… at this time, there are no concerns regarding the safety of the Mionix product."

2.    5-31-02 - FSIS "no objection" to the use of Poultry Wash.

"Therefore, we have no objections to the use of the Mionix Safe₂O^® / SafepHix^® Poultry Wash in federally inspected establishments in poultry operations prior to the chill tank provided it complies with established regulatory guidelines including FDA, EPA, and OSHA requirements."

-Currently, Mionix has no EPA approval for it's USA applications for Poultry Wash.

3.    2-5-03 - FSIS "no objection" to the use of Safe₂O^®  / SafepHix^® (RTE 03).

"FDA has evaluated the safety of use for the treatment of meat and poultry products with Safe₂O® / SafepHix^®for the treatment of meat and poultry products and has no safety concerns when the substances are added to food in accordance with the uses and limitations specified in Title 21 of the Code of Federal Regulations (CFR)."

"FSIS does not object to the use of Safe₂O^® / SafepHix^®as an antimicrobial agent for use on meat products but because data show that the use of Safe₂O^® / SafepHix^®has a sustained antimicrobial effect in treated product, its use is not consistent with FDA's definition of a processing aid listed in 21 CFR 101.100 (a)(3)(ii)."

"… FSIS feels that the data presented are sufficient to demonstrate the suitability of Safe₂O^® / SafepHix^®to treat sausage and sausage type products."

4.    2-24-03 - Clarification of Safe₂O^® / SafepHix^®approval - descriptive labeling.

"The use of Safe₂O^® / SafepHix^®in meat and poultry products was the subject of an acceptability determination dated February 5, 2002. Safe₂O^® / SafepHix^®( a solution of …..) is approved for use in non-standardized meat and poultry products as well as products with a standard of identity in Title 9 of the Code of Federal Regulations (CFR), provided the products with a standard of identity are descriptively labeled." (This was before the publishing of the FSIS rule regarding the use of any safe and suitable binder or Antimicrobial.)

5.    3-26-03 - FSIS further clarification of Safe₂O^® / SafepHix^®approval - descriptive labeling.

"…. The descriptive labeling approach may apply to any product with a standard of identity in 9 CFR, e.g., "Ham, Water Added, treated with an Antimicrobial solution to reduce microorganisms," etc." (This also was before the publishing of the FSIS rule regarding the use if any safe and suitable binder or Antimicrobial.)

6.    5-9-03 - FSIS "no objection" to the use of the term "acidic calcium sulfate" for labeling purposes.

7.    9-5-03 - With the implementation of the direct final rule, "Approving Ingredients Used in the Production of Meat and Poultry Products: Use of Any Safe and Suitable Binder or Antimicrobial Agent in Meat and poultry Products With Standards of Identity or Composition", standardized products which permit the addition of antimicrobial agents (e.g., hot dogs) may now be treated with Safe₂O^® / SafepHix^®and identified by their standardized name (as opposed to descriptively naming the product as described in the "acceptability determination").

The ingredients of the Safe₂O^® / SafepHix^®solution need to be listed in the descending order of predominance by weight or percentage in the ingredients statement on the product labeling.

When Safe₂O^® / SafepHix^®is applied to meat or poultry products that do not permit the addition of antimicrobial agents, however, the products will continue to need to be descriptively named, e.g, "Beef steak treated with an antimicrobial solution to reduce microorganisms."

8.    9-22-03 - e-Mail from FSIS regarding:

Suitability of RTE 03 (and RTE 01) on lunch meat loaves- "The validation data that was submitted during the acceptability determination was for the proposed external application to a cooked RTE sausage, i.e., hot dogs. We feel that this data is sufficient for other external applications to cooked RTE products, e.g., other types of sausage (e.g., bologna and pepperoni), and other cooked items such as lunch meat loaves."

The use of Mionix products to achieve Alternative 1 Lm status - as long as the plant has the validation and verification data the use of acidic calcium sulfate appears to satisfy both of the requirements for placing a post lethality exposed RTE product in Alternative 1."

9.    10-29-03 - FSIS "no objection" to the use of RTE 03:

a. On country cured hams for mold control.

b. On cured RTE pork products to prevent the growth of mold and to reduce and suppress the growth of Lm.

10.  11-5-03 - Descriptive labeling

11.  11-20-03 - Using ACS on product contact surfaces

12.  12-5-03 - FSIS "no objection" to the use of Ground Beef Formula in ground beef.

13.  12-12-03 - FSIS "no objection" to the use of RTE 01 on cooked whole muscle poultry.

14.  12-4-03 - Suitability for RTE boneless pork ribs - e-Mail from FSIS- "your previous acceptability determinations, i.e., raw ground beef, cooked RTE meat products, and hams will cover the proposed use on pork ribs." This suitability will be for both RTE 03 and RTE 01. The suitability for hams was given for RTE 03. The "no objection" letter of 9-5-03 allows for the removal of propionic acid, thus suitability for RTE 01.

15.  1-20-04 Suitability for raw pork ribs.

16.  1-22-04 - No objection to the use of Safe₂O^® / SafepHix^®RTE 01 to treat roast beef and other similarly cooked beef products.

For further information on Applications of our

“ Acidic Calcium Sulfate Based Products “

please call 719-265-9141

or email to
Applications@ACSProductInfo.com
or
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MATERIAL SAFETY DATA SHEET

ACS 100 /Acidic Calcium Sulfate

Kosher Food Additive/Ingredient Acidifier

PRODUCT NAME      ACS 100 - Acidic Calcium Sulfate                                           EMERGENCY NUMBER   800-424-9300   

MSDS NUMBER       14033                      PRODUCT USE                         Acidulant                

VERSION NUMBER   1.9                           DOT HAZARD CLASS                                8             

ISSUE DATE:            04/04/03                 DOT SHIPPING NAME:             Corrosive liquid, Acidic,

                                                                                                                Inorganic, N.O.S.

REVISION DATE:       09/09/07                 UN NUMBER                            3264

PREPARED BY:        ACS Technology       PACKAGING GROUP                                II

MANUFACTURER     Hydrite Chemical Co. for

ACS Technology

                                5470 Wilson Rd.

                                COS, CO 8099

                                719-265-9141

ABBREVIATION KEY: NA= Not Applicable   NE = Not Established   ND = Not Determined

CHEMICAL INDENTITY                                    HAZARDOUS                                      CAS REG#                                    PERCENTAGES

Acidic Calcium Sulfate                                         Yes                                                   NA                                                40 – 60

Water                                                                    No                                              7732-18-5                                          40 – 60

BOILING POINT: – 104ºC – 105ºC                        SPECIFIC GRAVITY: – (H₂O = 1.0) – 1. 10 - 1.13           ODOR: – Odorless and slightly acidic

PHYSICAL STATE: - Liquid                                   Appearance – clear to slightly cloudy or opaque       pH: - <1.0

FREEZING POINT:  - 5ºC

Exposure to significant quantities of liquid and/or mist may cause irritation or burns to body tissue. Swallowing of large quantities may be fatal.  Harmful if undiluted Acidic Calcium Sulfate is inhaled.  Excessive heat (>100^OC)  may cause volatility.  Slightly water reactive.  Contains strong inorganic acid. 

POTENTIAL HEALTH EFFECTS

Inhalation:  Inhalation of undiluted Acidic Calcium Sulfate may produces damaging effects  on the mucous membranes and upper respiratory tract. Symptoms may include irritation of the nose and throat.  May cause lung edema, a medical emergency.

Skin Contact: Corrosive. Symptoms of redness, pain, and burn can occur by skin contact with undiluted Acidic Calcium Sulfate.

Ingestion: Acidic Calcium Sulfate is a food additive, however ingestion of undiluted ACS 100 may  cause burns to the mouth, throat, and stomach.

Eye Contact: Contact with undiluted redness,  may cause blurred vision, and  pain & severe tissue burns.

Chronic Exposure: Chronic exposure to mist of the undiluted Acidic Calcium Sulfate may increase risk of cancer.

Aggravation of Pre-existing Conditions: Persons with pre-existing skin disorders or eye problems or impaired respiratory function may be more susceptible to the effects of undiluted Acidic Calcium Sulfate.

Inhalation:  Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention immediately.

Skin Contact: In case of contact, immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes.  Wash clothing before reuse.

Ingestion: If swallowed, DO NOT INDUCE VOMITNG. Give large quantities of water. Never give anything by mouth to an unconscious person. Get medical attention immediately.

Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.

ACS TECHNOLOGY                                                       Page 1 of 3          MSDS I4033 – ACS 100 Acidic Calcium Sulfate

Fire: Concentrated material is a strong dehydrating agent. Do not store around unapproved chemicals (see Section 10). 

Explosion: A mild exothermic reaction may occur  when undiluted Acidic Calcium Sulfate is added to water. 

Fire Extinguishing Media: Dry chemical, foam or carbon dioxide.  Water spray may be used to keep fire exposed containers cool.

Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. Structural firefighter's clothing is ineffective for fires involving this material. Stay away from sealed containers.

Ventilate area of leak or spill. Wear appropriate personal protective equipment. Isolate hazard area. Keep unnecessary and unprotected personnel from entering. Contain and recover liquid when possible. Neutralize with alkaline material (soda ash, lime), then absorb with an inert material (e.g., vermiculite, dry sand, earth), and place in a chemical waste container. Do not use combustible materials, such as saw dust. Do not flush to sewer. US regulations (CERCLA) require reporting spills and releases to soil, water, and air in excess of reportable quantities. The toll free number for the US Coast Guard National Response Center is 800-424-8802.

Store  in well ventilated storage area.  Protect from physical damage. Keep  away from incompatible materials. When diluting, always add ACS I00 to water; never add water to undiluted Acidic Calcium Sulfate.  

Airborne Exposure Limits:

For  undiluted Acidic Calcium Sulfate/ACS 100

-OSHA Permissible Exposure Unit (PEL): 1mg/m3 (TWA)

-ACGIH Threshold Unit Value (TLV): 1 mg/m3 (TWA), 3 mg/m3 (STEL),  A2 - suspected human carcinogen for undiluted Acidic Calcium Sulfate/ ACS 100 contained in strong inorganic acid mists.

Skin Protection: Wear impervious protective clothing, including boots, gloves, lab coat, apron or coveralls, as appropriate, to prevent skin contact.

Eye Protection: Use chemical safety goggles and/or a full face shield where splashing is possible. Maintain eye wash fountain and quick-drench

facilities in work area.

Stability: Stable under ordinary conditions of use and storage.

Hazardous Decomposition Products: Reacts with carbonates to generate carbon dioxide gas, and with cyanides and sulfides to form poisonous hydrogen cyanide and hydrogen sulfide respectively.

Hazardous Polymerization: Will not occur.

Incompatibilities: Potassium chlorate, potassium perchlorate, potassium permanganate, sodium, lithium, bases, organic material, halogens, metal acetyl ides, oxides and hydrides, metals (yields hydrogen gas), strong oxidizing and reducing agents and many other reactive substances.

Conditions to Avoid:  Excessive Heat (>100^OC) and incompatibles.

Toxicological Data: Oral rat LD₅₀: 2140 mg/kg; inhalation rat LC₅₀: 510 mg/m3/2H; standard Draize, eye rabbit, 250 µg (severe); investigated as a tumorigen, mutagen, reproductive effector (0.1N solution).

Carcinogenicity: Cancer Status: The International Agency for Research on Cancer (IARC) has classified "strong inorganic acid mists" as a known human carcinogen, (IARC category 1).

Environmental Fate: When released into the soil, this undiluted ACS 100 / Acidic Calcium Sulfate may leach into groundwater. When released into the air, this material may be removed from the atmosphere to a moderate extent by wet deposition. When released into the air, this material may be removed from the atmosphere to a moderate extent by dry deposition.

Environmental Toxicity: This undiluted Acidic Calcium Sulfate may be toxic to aquatic life.

Chemical waste generators must determine whether a discarded chemical is classified as a hazardous waste. US EPA guidelines for the classification determination are listed in 40 CFR Parts 261.3. Additionally, waste generators must consult state and local hazardous waste regulations to ensure complete and accurate classification.

RCRA P-Series: None listed.

RCRA U-Series: None listed.

ACS TECHNOLOGY                                                       Page 2 of 3          MSDS I4033 – ACS 100 Acidic Calcium Sulfate

Shipping Name:                      Corrosive liquid, Acidic, Inorganic, N.O.S (ACIDIC CALCIUM SULFATE)

Hazard Class:                          8

UN Number:                            UN3264

Packing Group:                      II

TSCA

CAS# 7664-93-9 is listed on the TSCA inventory.

Health & Safety Reporting List

None of the chemicals are on the Health & Safety Reporting List.

Chemical Test Rules

None of the chemicals in this product are under a Chemical Test Rule.

Section 12b

None of the chemicals are listed under TSCA Section 12b.

TSCA Significant New Use Rule

None of the chemicals in this material have a SNUR under TSCA.

SARA

Section 313

Acidic Calcium Sulfate may contain sulfuric acid (CAS# 7664-93-9, 95 98 0%), which is subject to the reporting requirements of Section 313 of SARA Title III and 40 CFR Part 373.

Clean Air Act:

This material does not contain any hazardous air pollutants. This material does not contain any Class 1 Ozone depletors. This material does not contain any Class 2 Ozone depletors.

Clean Water Act:

CAS# 7664-93-9 is listed as a Hazardous Substance under the CWA. None of the chemicals in this product are listed as Priority Pollutants under the CWA. None of the chemicals in this product are listed as Toxic Pollutants under the CWA.

OSHA:

None of the chemicals in this product are considered highly hazardous by OSHA.

STATE

CAS# 7664-93-9 can be found on the following state right to know lists: California, New Jersey, Florida, Pennsylvania, Minnesota, and Massachusetts.

California No Significant Risk Level: None of the chemicals in this product are listed. European/International Regulations

European Labeling in Accordance with EC Directives

Hazard Symbols: C

MSDS Creation Date: 6/20/2005

Revision #4 Date: 11/16/2011

The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall ACS Technology be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ASC Technology has been advised of the possibility of such damages

ACS TECHNOLOGY                                                       Page 3 of                 MSDS I4033 – ACS 100 / Acidic Calcium Sulfate