United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 1998_register executive 2010-09-24 article Proposed Rules D09002ee1be003049 D09002ee1be0030ef United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing a tentative final rule to amend its regulations to affirm that egg white lysozyme enzyme preparation, when labeled by the common or usual name ``egg white lysozyme'' to identify its source, is generally recognized as safe (GRAS) for use in preventing late blowing of cheese caused by the bacterium Clostridium tyrobutyricum during cheese production. This action is in response to a petition submitted by Fordras S.A. (formerly SPA-Societa Prodotti Antibiotici S.p.A.). FDA has tentatively concluded that this use of the egg white lysozyme enzyme preparation is GRAS only when the ingredient statement for both bulk and packaged food that contains cheese manufactured using egg white lysozyme includes the common or usual name ``egg white lysozyme'' to identify the source of the protein. To give interested persons an opportunity to comment on this condition of use required for GRAS status, FDA is issuing this tentative final rule. 63 FR 12421 https://www.govinfo.gov/app/details/FR-1998-03-13/98-6571 98-6571 fr13mr98-21 4160-01-F Docket No. 89G-0393 https://www.govinfo.gov/app/details/FR-1998-03-13/98-6571 https://www.govinfo.gov/content/pkg/FR-1998-03-13/html/98-6571.htm https://www.govinfo.gov/content/pkg/FR-1998-03-13/pdf/98-6571.pdf 6 p. 12421 12426 63 FR 12421 Title 21 Part 184 21 CFR Part 184 Direct Food Substances Affirmed as Generally Recognized as Safe; Egg White Lysozyme; Federal Register Vol. 63, Issue PRORULE 98-6571 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1998-05-27 Docket No. 89G-0393 4160-01-F 98-6571 Tentative final rule.

The Food and Drug Administration (FDA) is issuing a tentative final rule to amend its regulations to affirm that egg white lysozyme enzyme preparation, when labeled by the common or usual name ``egg white lysozyme'' to identify its source, is generally recognized as safe (GRAS) for use in preventing late blowing of cheese caused by the bacterium Clostridium tyrobutyricum during cheese production. This action is in response to a petition submitted by Fordras S.A. (formerly SPA-Societa Prodotti Antibiotici S.p.A.). FDA has tentatively concluded that this use of the egg white lysozyme enzyme preparation is GRAS only when the ingredient statement for both bulk and packaged food that contains cheese manufactured using egg white lysozyme includes the common or usual name ``egg white lysozyme'' to identify the source of the protein. To give interested persons an opportunity to comment on this condition of use required for GRAS status, FDA is issuing this tentative final rule.

Submit written comments by May 27, 1998. Linda S. Kahl, Center for Food Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-418-3101. Vol. 63, no. 49 Office of the Federal Register, National Archives and Records Administration 1998-03-13 continuing daily deposited born digital 232 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1998-03-13 P0b002ee180a5cd8c 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13mr98 https://www.govinfo.gov/app/details/FR-1998-03-13 https://www.govinfo.gov/content/pkg/FR-1998-03-13/pdf/FR-1998-03-13.pdf fdlp 12383 12602 DGPO 2010-09-24 2023-05-06 FR-1998-03-13 machine generated eng FR FR-1998-03-13 63 49