Distribution date: 12 June 2014 | Final date for Comment: 11 August 2014

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Naproxen on the Prescription Drug List (PDL). Only the human part of the PDL is proposed to be revised.</span></span>

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Regular notification

Distribution date: 12 June 2014 | Final date for Comment: 11 August 2014

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Naproxen on the Prescription Drug List (PDL). Only the human part of the PDL is proposed to be revised.</span></span>

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Regular notification

Distribution date: 18 June 2014 | Final date for Comment: 17 August 2014

<p align="left" style="text-align:left;"><span style="font-size:small;font-face:Verdana;"><span style="font-size:9.5pt;">Specifies the materials, construction and the preferred sizes of domestic aluminum cooking pots (suffuria) and the lids. The fourth revision is undertaken to cater for heavy duty, the large sized cooking pots which are suitable for commercial, institutional and communities use. This ensures safe use by consumers through specifying chemical composition of the materials suitable for food preparation and storage. The standard shall ensure</span></span><span style="font-size:small;font-face:Verdana;"><span style="font-family:'Verdana','sans-serif';font-size:9.5pt;">harmonization of differing dimensions of aluminum cooking pots and lids currently in the domestic market.</span></span></p>

Products Covered: Kitchen equipment

Regulation Type: Regular notification

Distribution date: 18 June 2014 | Final date for Comment: 17 August 2014

<p align="left" style="text-align:left;"><span style="font-size:small;font-face:Verdana;"><span style="font-size:9.5pt;">Specifies the materials, construction and the preferred sizes of domestic aluminum cooking pots (suffuria) and the lids. The fourth revision is undertaken to cater for heavy duty, the large sized cooking pots which are suitable for commercial, institutional and communities use. This ensures safe use by consumers through specifying chemical composition of the materials suitable for food preparation and storage. The standard shall ensure</span></span><span style="font-size:small;font-face:Verdana;"><span style="font-family:'Verdana','sans-serif';font-size:9.5pt;">harmonization of differing dimensions of aluminum cooking pots and lids currently in the domestic market.</span></span></p>

Products Covered: Kitchen equipment

Regulation Type: Regular notification

Distribution date: 18 June 2014 | Final date for Comment: 18 August 2014

Draft resolution that adopts provisions on the mandatory declaration in the label of packaged food, of recognized sources of food allergies or food intolerances in sensitive persons. This resolution applies to food, ingredients, food additives, technological coadjuvants and raw material which are packaged in the absence of consumers, including those intended to be used exclusively for industrial processing and at food establishments. This resolution is complementary to the Resolution number 259, of 20 September 2002, which approves the technical regulation for labelling packaged food, and to the Law 10.674, of 16 May 2003, which establishes mandatory providing information on the presence of gluten in marketed food products. The following are recognized sources of food allergies or food intolerances in sensitive persons: I. Cereals containing gluten, namely wheat, rye, barley, oats and their hybridised strains; II. Crustaceans; III. Eggs; IV. Fish; V. Peanut; VI. Soy; VII. Milk; VIII. Almond (Prunus dulcis); IX. Hazelnut (Corylus spp.); X. Cashew nut (Anacardium occidentale); XI. Brazil nuts (Bertholletia excelsa); XII. Macadamia (Macadamia spp.); XIII. Nut (Juglans spp.); XIV. Pecan (Carya illinoensis); XV. Pistachio (Pistacia vera L.); and XVI. Sulphites (sulphur dioxide and its salts) in concentration equal to or greater than 10 (ten) parts per million (ppm), expressed in sulphur dioxide. Alterations in the list provided here within can be made upon updates on Codex Alimentarius guidelines or scientific evidences showing the cause-effect of the food consumption and adverse events, its epidemiological magnitude and its severity. The food, ingredients, additives, technological coadjuvants and raw materials which are packaged in absence of consumers, including those intended to be used for manufacturing and for food establishments must contain the declaration: Contains Gluten or Gluten Free, as appropriate. Food that are, derives from or have been intentionally added of ingredients, food additives, technological coadjuvants or raw materiasl from recognized sources of food allergies or food intolerances described in sections II to XVI of article 4, in any quantity, must bring the declaration: Allergic: Contains (source names), or Allergic: Contains derivatives of (source names), as appropriate. In cases that food, ingredients, food additives, technological coadjuvants or raw materials have risks of causing incidental contamination from recognized sources of food allergies or food intolerances described in sections II to XV of article 4 , must inform in its label the declaration: Allergic: May Contain (source names). Declarations required at articles 6, 7 and 8 of this Resolution must be grouped near the ingredients list on the label, in a white background frame and in black characters of the same type, complying with height requirements established in the annex of this Resolution. This Resolution revokes Resolution RDC number 40 of 8 February 2002 which approves the technical regulation on labelling of packed food and beverage that contain gluten.

Products Covered: I. Cereals containing gluten, namely wheat, rye, barley, oats and their hybridised strains; II. Crustaceans; III. Eggs; IV. Fish; V. Peanut; VI. Soy; VII. Milk; VIII. Almond (Prunus dulcis); IX. Hazelnut (Corylus spp.); X. Cashew nut (Anacardium occidentale); XI. Brazil nuts (Bertholletia excelsa); XII. Macadamia (Macadamia spp.); XIII. Nut (Juglans spp.); XIV. Pecan (Carya illinoensis); XV. Pistachio (Pistacia vera L.); and XVI. Sulphites (sulphur dioxide and its salts) in concentration equal to or greater than 10 (ten) parts per million (ppm), expressed in sulphur dioxide.

Regulation Type: Regular notification

Distribution date: 18 June 2014 | Final date for Comment: 18 August 2014

Draft resolution that adopts provisions on the mandatory declaration in the label of packaged food, of recognized sources of food allergies or food intolerances in sensitive persons. This resolution applies to food, ingredients, food additives, technological coadjuvants and raw material which are packaged in the absence of consumers, including those intended to be used exclusively for industrial processing and at food establishments. This resolution is complementary to the Resolution number 259, of 20 September 2002, which approves the technical regulation for labelling packaged food, and to the Law 10.674, of 16 May 2003, which establishes mandatory providing information on the presence of gluten in marketed food products. The following are recognized sources of food allergies or food intolerances in sensitive persons: I. Cereals containing gluten, namely wheat, rye, barley, oats and their hybridised strains; II. Crustaceans; III. Eggs; IV. Fish; V. Peanut; VI. Soy; VII. Milk; VIII. Almond (Prunus dulcis); IX. Hazelnut (Corylus spp.); X. Cashew nut (Anacardium occidentale); XI. Brazil nuts (Bertholletia excelsa); XII. Macadamia (Macadamia spp.); XIII. Nut (Juglans spp.); XIV. Pecan (Carya illinoensis); XV. Pistachio (Pistacia vera L.); and XVI. Sulphites (sulphur dioxide and its salts) in concentration equal to or greater than 10 (ten) parts per million (ppm), expressed in sulphur dioxide. Alterations in the list provided here within can be made upon updates on Codex Alimentarius guidelines or scientific evidences showing the cause-effect of the food consumption and adverse events, its epidemiological magnitude and its severity. The food, ingredients, additives, technological coadjuvants and raw materials which are packaged in absence of consumers, including those intended to be used for manufacturing and for food establishments must contain the declaration: Contains Gluten or Gluten Free, as appropriate. Food that are, derives from or have been intentionally added of ingredients, food additives, technological coadjuvants or raw materiasl from recognized sources of food allergies or food intolerances described in sections II to XVI of article 4, in any quantity, must bring the declaration: Allergic: Contains (source names), or Allergic: Contains derivatives of (source names), as appropriate. In cases that food, ingredients, food additives, technological coadjuvants or raw materials have risks of causing incidental contamination from recognized sources of food allergies or food intolerances described in sections II to XV of article 4 , must inform in its label the declaration: Allergic: May Contain (source names). Declarations required at articles 6, 7 and 8 of this Resolution must be grouped near the ingredients list on the label, in a white background frame and in black characters of the same type, complying with height requirements established in the annex of this Resolution. This Resolution revokes Resolution RDC number 40 of 8 February 2002 which approves the technical regulation on labelling of packed food and beverage that contain gluten.

Products Covered: I. Cereals containing gluten, namely wheat, rye, barley, oats and their hybridised strains; II. Crustaceans; III. Eggs; IV. Fish; V. Peanut; VI. Soy; VII. Milk; VIII. Almond (Prunus dulcis); IX. Hazelnut (Corylus spp.); X. Cashew nut (Anacardium occidentale); XI. Brazil nuts (Bertholletia excelsa); XII. Macadamia (Macadamia spp.); XIII. Nut (Juglans spp.); XIV. Pecan (Carya illinoensis); XV. Pistachio (Pistacia vera L.); and XVI. Sulphites (sulphur dioxide and its salts) in concentration equal to or greater than 10 (ten) parts per million (ppm), expressed in sulphur dioxide.

Regulation Type: Regular notification

Distribution date: 20 June 2014 | Final date for Comment: 08 August 2014

Draft resolution of the pharmacopoeial monographs on the heparin sodium from bovine and porcine in the Brazilian Pharmacopoeia. The heparin sodium from bovine is extracted from the bovine intestine and contains a mix of polysaccharide chains with different molecular weight. It is composed of units of &#61537;-D-glucosamine and acid &#61537;&#61485;iduronic 2-sulfated. The units of &#61537;-D-glucosamine present a more heterogeneous pattern of sulphatation in comparison with the heparin from porcine. In special we observe higher proportion of units of &#61537;-D-glucosamine non-sulphated in the position 6. It has anticoagulant activity by the inhibition of many factors of the coagulation system, prolonging the time of coagulation in blood. This occurs mainly through potentiation of the Xa factor inactivation and of the thrombin through the antithrombin. It contains, at least, 160 units of anti-factor lla activity for mg of heparin, respectively, in relation to desiccated substance. The reason of the anti-factor Xa activity for the anti-factor lla activity must be of 1.0 ± 0.1. The animals from which the heparin is extracted must fulfil the sanitary requirements of the species and the manufacturing process must ensure the elimination or the inactivation of infectious agents. The heparin sodium from porcine is extracted from the intestine of the porcine and contains a mix of polysaccharide chains with different molecular weight. It is composed, preponderantly, for alternated units of &#61537;-D-glucosamine N- and 6- disulfated and acid &#61537;&#61485;iduronic 2-sulfated. It has anticoagulant activity due to the inhibition of many factors of the coagulation system, prolonging the time of coagulation in blood. This occurs mainly through potentiation of the Xa factor inactivation and of the thrombin through the antithrombin. It contains, at least, 180 units of anti-factor lla activity for mg of heparin, in relation to desiccated substance. The reason of the anti-factor Xa activity for the anti-factor lla activity must be 1.0 ± 0.1. The animals from which the heparin is extracted must fulfil the sanitary requirements of the species in question and the manufacturing process must ensure the elimination or the inactivation of infectious agents. These monograph proposals set standards for the identity, dosage (according to methods Anti-factor Xa activity and Anti-factor IIa activity / ion-exchange high-performance liquid chromatography technique for detection and separation of possible contaminants of the heparin), characteristics, purity assays, biological safety tests, packaging, storing and labeling of the heparin sodium from bovine and porcine in the Brazilian Pharmacopoeia.

Products Covered: Pharmacopoeial monographs on the heparin sodium from bovine and porcine in the Brazilian Pharmacopoeia

Regulation Type: Regular notification

Distribution date: 20 June 2014 | Final date for Comment: 08 August 2014

Draft resolution of the pharmacopoeial monographs on the heparin sodium from bovine and porcine in the Brazilian Pharmacopoeia. The heparin sodium from bovine is extracted from the bovine intestine and contains a mix of polysaccharide chains with different molecular weight. It is composed of units of &#61537;-D-glucosamine and acid &#61537;&#61485;iduronic 2-sulfated. The units of &#61537;-D-glucosamine present a more heterogeneous pattern of sulphatation in comparison with the heparin from porcine. In special we observe higher proportion of units of &#61537;-D-glucosamine non-sulphated in the position 6. It has anticoagulant activity by the inhibition of many factors of the coagulation system, prolonging the time of coagulation in blood. This occurs mainly through potentiation of the Xa factor inactivation and of the thrombin through the antithrombin. It contains, at least, 160 units of anti-factor lla activity for mg of heparin, respectively, in relation to desiccated substance. The reason of the anti-factor Xa activity for the anti-factor lla activity must be of 1.0 ± 0.1. The animals from which the heparin is extracted must fulfil the sanitary requirements of the species and the manufacturing process must ensure the elimination or the inactivation of infectious agents. The heparin sodium from porcine is extracted from the intestine of the porcine and contains a mix of polysaccharide chains with different molecular weight. It is composed, preponderantly, for alternated units of &#61537;-D-glucosamine N- and 6- disulfated and acid &#61537;&#61485;iduronic 2-sulfated. It has anticoagulant activity due to the inhibition of many factors of the coagulation system, prolonging the time of coagulation in blood. This occurs mainly through potentiation of the Xa factor inactivation and of the thrombin through the antithrombin. It contains, at least, 180 units of anti-factor lla activity for mg of heparin, in relation to desiccated substance. The reason of the anti-factor Xa activity for the anti-factor lla activity must be 1.0 ± 0.1. The animals from which the heparin is extracted must fulfil the sanitary requirements of the species in question and the manufacturing process must ensure the elimination or the inactivation of infectious agents. These monograph proposals set standards for the identity, dosage (according to methods Anti-factor Xa activity and Anti-factor IIa activity / ion-exchange high-performance liquid chromatography technique for detection and separation of possible contaminants of the heparin), characteristics, purity assays, biological safety tests, packaging, storing and labeling of the heparin sodium from bovine and porcine in the Brazilian Pharmacopoeia.

Products Covered: Pharmacopoeial monographs on the heparin sodium from bovine and porcine in the Brazilian Pharmacopoeia

Regulation Type: Regular notification

Distribution date: 23 June 2014 | Final date for Comment: 22 August 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; Product requirements; Labelling requirements; Sampling; Conformity assessment tests; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;

Products Covered: 3604.10.00 and 3604.90.00 ;

Regulation Type: Regular notification

Distribution date: 23 June 2014 | Final date for Comment: 22 August 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; Product requirements; Labelling requirements; Sampling; Conformity assessment tests; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;

Products Covered: 3604.10.00 and 3604.90.00 ;

Regulation Type: Regular notification