SDSs issued by DuPont in Europe are in compliance with all applicable European legislation requirements, including REACH requirements as interpreted by the European Commission. 

Due to practical challenges of implementing the SDS changes required by REACH before the start of the Registration process, the European Commission supported the CEFIC position with respect to the following key points:

• The only requirements that could reasonably be implemented by June 1, 2007 were mainly format changes. (These include reversing the content of Sections 2 and 3, inserting the e-mail address of the individual responsible for creating the SDS in Section 1, and for substances not classified as dangerous, adding the reason for indicating the substance in Section 3).
• SDSs that do not need to be revised for reasons other than the above format changes can stay in the pre-REACH format and are considered to be still in compliance because their content is correct. For newly created SDSs, and for revised SDSs, the format changes must be implemented.
• All changes required by REACH as described in articles 31 and Annex II of the Regulation should be implemented before Dec 1, 2010, which coincides with the first deadline for registration. Until that date, the SDSs circulating in Europe will be in 2 different formats.

DuPont has implemented the above recommendations of the European Commission. On this basis, our SDSs comply with the REACH requirements as currently defined and interpreted by the European Commission. 

The manufacturing facilities in Germany (Stade, Bomlitz, and Bitterfeld-Wolfen) are certified for Environmental Management for ISO 14001.

See attachments below.

• 004486 QM15_UM15 2017-09-22 englisch Germany Exp 2020-09-21.pdf (741.33 KB)

Certain types and grades of METHOCEL cellulose ethers are soluble in certain liquid polar organic reagents and mixtures of polar organic reagents and water. Therefore, METHOCEL products exhibit a useful and unique combination of polar organic solubility and water solubility. However, there is a key difference that one needs to understand. Although METHOCEL gums are well known to exhibit inverse solubility in water (they are insoluble in hot water but soluble in cool water), their solubility behavior in organic liquids reflects a normal expectation of increasing solubility with rising temperature. Also, see METHOCEL Solution Preparation.

Generally, formulating METHOCEL products into a waterless (nonaqueous) system follows the same steps as for dissolution in water except for reversing the temperatures of the starting and finishing steps. The first step is dispersion of the polymer powder into the polar organic liquid. This is best accomplished by adding the METHOCEL™ into an organic liquid which is at a cool or room temperature (minimum solvency toward METHOCEL). Once the polymer is well dispersed (wetted out), the mixture should be stirred and heated until a solution forms. The solvency of the liquid organic reagent toward METHOCEL increases with increasing temperature (just the opposite of water solvency). Depending on the particular organic reagents, the mixture may or may not form clear solutions and may form a gel or precipitate upon cooling.

Typical polar organic liquids that may function as solvents include many types of short, medium and long chain fatty acids, alcohols, esters and amides. Many flavor compounds are moderate or excellent solvents also. Many METHOCEL products are soluble in short chain hydroalcoholic solvent systems if the water content is greater than 10%. METHOCEL 311 shows the best solubility in short chain alcohol (methanol, ethanol, i-propanol) systems if the water is less than 10%. Generally, the hydroxypropyl methylcellulose types (METHOCEL 311, E, F, J and K) show greater solubility in polar organic liquids than methylcellulose (A and SG A) types.

See the CEFIC, European Chemical Industry Council, web site or the file attachments below.

• CEFIC Safety Instruction, Full Version (English).pdf (603.86 KB)
• CEFIC Safety Instruction, Executive Summary (English).pdf (524.81 KB)
• CEFIC Safety Instruction, Full Version (German).pdf (609.05 KB)
• CEFIC Safety Instruction, Executive Summary (German).pdf (527.80 KB)

The apparent viscosity of an aqueous solution of a METHOCEL cellulose ether is proportional to the molecular weight or chain length of the specific METHOCEL product used. Commercial designations of METHOCEL products are based on viscosity values determined in water at 20°C, with a concentration of 2% METHOCEL. The measurement methods used are described in the current ASTM monographs D1347 and D2363. The correlation between the number average molecular weight (Mn) and the commercial viscosity designation for METHOCEL A cellulose ethers is shown in the figure below.

The table below provides further information regarding the correlation of number average molecular weight with the commercial viscosity designation. Intrinsic viscosity is the limiting quotient of the specific viscosity divided by the concentration as infinite dilution is approached (as the concentration approaches zero). The number average molecular weight (Mn) is calculated from the limiting osmotic pressure of the solvent as the concentration of the solute approaches zero. The average molecular weight (Mw) will be 3 to 10 times the Mn.

Viscosity of Methylcellulose of Various Molecular Weights

The DuPont product name for USP Hypromellose is METHOCEL™ cellulose ether (K, F, or E type) Premium grade Hydroxypropyl Methylcellulose.  The substitution type is incorporated into the DuPont product name as shown in the table below.

The full nomenclature is described as follows. METHOCEL is a trademark of The Dow Chemical Company for a line of cellulose ether products. An initial letter identifies the type of cellulose ether. "A" identifies methylcellulose products. "E", "F", and "K" identify different hydroxypropyl methylcellulose (USP Hypromellose) products. The number that follows identifies the viscosity in millipascal-seconds (mPa.s) of that product measured at 2% concentration in water at 20°C. In designating viscosity, the letter "C" is frequently used to represent 100 and the letter "M" is used to represent 1,000.  In the USP this is referred to as the labeled viscosity.  It is also given on the DuPont sales specification as the nominal viscosity.

Several different suffixes are also used to identify special products. "P" is sometimes used to identify METHOCEL Premium grade products; Premium grade products are compliant with the United States Pharmacopeia (USP), European Pharmacopeia (PhEur), and the Japanese Pharmacopeia (JP).  "LV" refers to special Low Viscosity products, "CR" denotes a Premium, Controlled Release grade. "FG" identifies Food Grade products.  "G" identifies Granular products, the letter "S" identifies Surface-treated, cold-water dispersible products. Developmental grades are denoted by the letter "X" plus a second letter (usually "U" or "Y") plus a five-digit code.

Example: METHOCEL J5MS is a Standard grade Hydroxypropyl methylcellulose product with a viscosity of 5,000 mPa s, which has been surface-treated for easy dispersion.

The METHOCEL cellulose ether packages are filled according to the legal requirement for size of container and the weight contained.  The requirement is listed in the NIST Handbook for Weights and Measures, 4th edition, Appendix A, Table 2.5.

Bags:  According to the NIST handbook, packages labeled by weight more than 42.40 lb to 54.40 lb allow for +/- 0.5 lb weight variance.  This equates to a range of 49.5 - 50.5 lbs.
 
25kg  (55.1 lb) Drums:  According to the NIST handbook, packages labeled by weight more than 24.67 kg or 54.40 lb allow for 2% weight variance.  For 55.1 lb (25 kg) drums, this equates to a range of +/- 1.1 lbs resulting in a range of 54.0 to 56.2 lbs.   
 
50kg (110.2 lb) Drums:  According to the NIST handbook, packages labeled by weight more than 24.67 kg or 54.40 lb allow for 2% weight variance.  For 110.2 lb (50kg) drums, this equates to a range of +/- 2.2 lbs resulting in a range of 108.0 to 112.4 lbs.

General properties common to the whole family of METHOCEL cellulose ether products are listed below. Individual METHOCEL products exhibit these properties to varying degrees and may have additional properties that are desirable for specific applications.

Water solubility - METHOCEL cellulose ethers dissolve in water with no sharp solubility limit.  Surface-treated and granular METHOCEL products can be added directly to aqueous systems.  This feature provides exceptional handling flexibility and control of solubilization rate.  Although untreated METHOCEL powders are soluble in cold water, they must first be thoroughly dispersed in the water to prevent lumping.  The maximum concentration is limited only by solution viscosity.

Organic solubility - Certain types and grades of METHOCEL cellulose ethers are also soluble in binary organic and organic solvent/water systems, providing a unique combination of organic solubility and water solubility.

No ionic charge - METHOCEL cellulose ethers are nonionic and will not complex with metallic salts or other ionic species to form insoluble precipitates.

Thermal gelation - Aqueous solutions of METHOCEL products gel when heated above a particular temperature, providing controllable quick-set properties.  Unlike gels formed by protein thickeners, the gels go back into solution upon cooling.

Surface activity - METHOCEL cellulose ether products act as surfactants in aqueous solutions to provide emulsification, protective colloid action, and phase stabilization. Surface tensions range from 42 to 64 mN/m. The surface tension of water is 72 mN/m; a typical surfactant has a surface tension of 30 mN/m.

Metabolic inertness - Used as food and drug additives, METHOCEL products do not add calories to the diet.

Enzyme resistance - Enzyme-resistant METHOCEL products provide excellent viscosity stability during long-term storage.

Low taste and odor - METHOCEL cellulose ethers have excellent (low) flavor and aroma properties, which is important in food and pharmaceutical applications.

pH stability - METHOCEL cellulose ethers are stable over a pH range of 3 to 11.

Water retention - METHOCEL cellulose ethers are highly efficient water-retention agents. This is valuable in food products, ceramics, coatings on adsorbent construction substrates, and many other applications.

Thickening - METHOCEL cellulose ethers thicken both aqueous and nonaqueous systems. The viscosity is related to the molecular weight, chemical type, and concentration of the specific METHOCEL product.

Film formation - METHOCEL products form clear, tough, flexible films that are excellent barriers to oils and greases. In food applications, this property is often used to retain moisture and prevent oil absorption during cooking.

Binding - METHOCEL cellulose ethers are used as high-performance binders for pigments, paper, structured foods, pharmaceutical products, and ceramics.

Lubrication - METHOCEL products are used to reduce friction in rubber, cement, and ceramic extrusions. They are also used to improve pumpability of concrete and spray plasters, such as stucco, and in food applications as lubricity aids in extrusion and other forming processes.

Suspending - METHOCEL products are used to control settling of solid particles, for example, herbs and spices in salad dressings, solids in ceramic slips, and antacid suspensions.

Protective colloidal action - METHOCEL products are used to prevent droplets and particles from coalescing or agglomerating.

Emulsification - METHOCEL cellulose ethers stabilize emulsions by reducing surface and interfacial tensions and by thickening the aqueous phase.

METHOCEL cellulose ether products are water-soluble polymers derived from cellulose, the most abundant polymer in nature.  Hydroxypropyl methylcellulose (HPMC) and methylcellulose (MC) are manufactured from highly purified cellulose which is further modified to obtain the desired properties. They are inert, high purity powders with no caloric value, and are virtually colorless, odorless and tasteless.

Premium and Food Grades of METHOCEL HPMC and MC products are recognized as acceptable for use in food by the food regulatory bodies of almost every country. Hydroxypropyl methylcellulose and methylcellulose are listed in the current U.S. CFR, the Food Chemicals Codex and the International Codex Alimentarius. METHOCEL Premium products are also included in the current U.S. Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia.

Additionally, methylcellulose is Generally Recognized as Safe (GRAS) by the U.S. FDA. All METHOCEL HPMC Food Grade Products are considered by the FDA to be GRAS per GRAS Notification GRN 000213.  See the following link for the US FDA Agency Response Letter: 
 http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-foods-gen/documents/document/ucm269093.pdf.

METHOCEL Premium and Food Grade products are certified as Kosher and pareve for year-round and Passover use by the Union of Orthodox Congregations of America and they all conform to HALAL requirements.