مليىان

المعلومات الرئيسية

  • اسم تجاري:
  • مليىان
  • الشكل الصيدلاني:
  • COATED TABLETS
  • طريقة التعاطي:
  • PER OS
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • DELPHARM LILLE, SAS, FRANCE

المستندات

الأقلمة

  • متاح في:
  • مليىان
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • GESTODENE AND ESTROGEN
  • الخصائص العلاجية:
  • Oral contraceptive.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 109122909400
  • تاريخ الترخيص:
  • 01-01-2013
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة

Layout Management AM   Seite  1  Bayer Schering Pharma

Mandant:  534   Stof f-Nr .:  64013113   PZ:  2613A-3   Code-Nr .:  20

Bezeichnung:  Meliane 1x21,  3x21   Aufmachung:  Israel BSP

Farben:  Black

Version:  25.11.2008/01   Freigabe:

COMPOSITION:

Each tablet contains:

Gestodene        0.075 mg

Ethinylestradiol  0.020 mg

Inactive ingredients:

Lactose monohydrate, maize starch, povidone 25000, magnesium stearate, sucrose, povidone 

700000, polyethylene glycol 6000, calcium carbonate, talc, montanglycol wax (wax E). 

Each tablet contains: 37.15 mg lactose monohydrate.

Each tablet contains: 19.66 mg sucrose.

THERAPEUTIC GROUP: Combined oral contraceptive pill (estrogen and progestogen). 

THERAPEUTIC ACTIVITY: Oral contraception.

WHEN SHOULD THE PREPARATION NOT BE USED?

Do not use this medicine if you are pregnant or if you suspect you are pregnant.

Do not use this medicine if you are sensitive to any of its ingredients. 

Do  not  use  a  combined  oral  contraceptive  pill,  such  as  Meliane,  in  the  following 

conditions: 

If  you  are  suffering,  or  have  suffered  in  the  past,  from  an  illness  that  affects  the  blood 

circulation, especially thrombotic events (thrombosis - the formation of a blood clot) that 

may occur in the blood vessels of the legs (deep vein thrombosis), in the lungs (pulmonary 

embolism), in the heart (heart attack), in the brain (cerebrovascular accident as a result of 

a blood clot or hemorrhage), or in other parts of the body. 

In cases, past or present, that signify a first sign of heart attack (e.g. angina pectoris or 

chest pain) or of cerebrovascular accident (e.g. transient ischemic attack or mild reversible 

stroke). A history of migraine accompanied by vision disturbances, speech disturbances or 

weakness/tingling  sensation  in  any  part  of  the  body,  in  cases  of  diabetes  with  vascular 

damage, in past or present cases of pancreatitis accompanied by high blood lipid levels, in 

cases  of  jaundice  or  acute  liver  disease,  past  or  present  cases  of  hormone  dependent 

tumors (e.g. cancer of the breast or of the reproductive organs), past or present benign or 

malignant liver tumors, undiagnosed vaginal bleeding, sickle cell anemia, lipid metabolism 

disorders, history of aggravated otosclerosis during pregnancy, itching over the entire body, 

jaundice during pregnancy.

If any of the above cases occurs for the first time while using this medicine, discontinue use 

and  consult  your  attending  doctor.  In  the  meantime  use  non-hormonal  contraceptive 

measures.

Do not use the medicine without consulting a doctor before starting treatment:

If you are breastfeeding.

If you smoke, if you are suffering, or have suffered in the past, from impaired function of the 

heart - abnormal valve or arrhythmia, the liver (jaundice) or gallbladder, the kidney/urinary 

tract,  and  also  if  you  are  suffering  or  have  suffered  from  one  of  the  following  ailments: 

hypertension,  diabetes,  overweight,  varicose  veins,  phlebitis,  family  history  of  thrombosis, 

heart  attack  or  cerebrovascular  accident,  migraine,  epilepsy,  high  levels  of  cholesterol  or 

triglycerides in the blood (also if there is a family history), family history of breast cancer, 

Crohn’s disease, ulcerative colitis, systemic lupus erythematosus, hemolytic uremic syndrome, 

conditions  which  occur  for  the  first  time  or  worsen  in  the  course  of  pregnancy  or  taking 

hormones,  such  as  porphyria,  a  history  of  gestational  herpes,  Sydenham’s  chorea  (a 

neurological  disease),  chloasma  (pigment  patches  on  the  skin,  especially  the  face), 

depression, multiple sclerosis, or intolerance to contact lenses.

If any of the above phenomena occurs for the first time, recurs or worsens while using the 

medicine, consult your doctor.

HOW WILL THE MEDICINE AFFECT YOUR DAILY LIFE?

The risk of arterial thrombosis and serious cardiovascular side effects associated with oral 

contraceptive pill increases with age. This risk increases in women who are heavy smokers, 

especially if they are above 35 years of age. It is therefore recommended not to smoke while 

using the medicine.

WARNINGS:

This medicine, like every oral contraceptive pill, does not protect you from contracting AIDS 

or any other sexually transmitted disease.

Before  starting  treatment,  you  should  undergo  a  complete  general  and  gynecological 

examination and ascertain that you are not pregnant.

As with any long-term use of hormonal preparations, if you are  using this medicine for  a 

prolonged period, you should visit your doctor every 6 months for a routine gynecological 

examination. It is also recommended that you have your blood pressure monitored every 6 

months.

Family  history  should  be  seriously  taken  into  consideration.  Blood  coagulation  disorders 

must be ruled out if any member of the family has suffered a thrombo-embolic disease (for 

instance, deep vein thrombosis, cerebrovascular accident, myocardial infarction) at a young 

age.

Venous thrombosis is rare. 

The  risk  of  developing  venous  thrombosis  while  taking  oral  contraceptive  pill  is  greatest 

Venous thrombosis can develop even if you are not taking an oral contraceptive pill; it can 

occur even if you become pregnant. The risk of venous thrombosis is higher among users of 

the pill than among non-users, but it is not as great as the risk during pregnancy.

Rarely, blood clots may form in the blood vessels of the heart (causing heart attack), or of the 

brain (causing stroke). In the rarest cases, blood clots may occur in the liver, intestines, kidneys 

or in the eyes. Sometimes thrombosis may cause functional impairments or even death.

The risk of thrombosis increases temporarily after surgeries or during periods of immobilization. 

Therefore, if you have to undergo surgery or be hospitalized, inform your doctor at least 4 

weeks in advance that you are taking the pill. If you develop high blood pressure while using 

the medicine, you may have to stop using it. 

Among  women  who  used  oral  contraceptive  pill  a  few  more  cases  of  breast  cancer  were 

diagnosed than among women of the same age who did not use the pill. This small increase 

in the number of breast cancer diagnoses gradually disappears during the 10 years following 

discontinuation of taking the pill.

It is not known if the difference is caused as a result of using the pill. It may be that the fact 

that  these  women  were  examined  more  frequently  led  to  earlier  diagnosis  of  the  breast 

cancer.

In rare cases, benign tumors of the liver were observed and in rarer cases, malignant tumors 

of  the  liver  were  observed,  that  led  in  isolated  cases  to  dangerous  intra-abdominal 

hemorrhage,  following  the  use  of  the  oral  contraceptive  pill.  Thus,  you  should  notify  your 

doctor of any severe pain in the upper abdomen that does not disappear spontaneously after 

a short time. 

The  most  important  risk  factor  for  cervical  cancer  is  a  prolonged  viral  infection  caused  by 

human  papillomavirus.  Several  studies  have  shown  that  prolonged  use  of  the  pill  may 

contribute to increasing the risk; however, controversy still exists as to whether these findings 

may also be related to other factors, such as cervical examinations, sexual habits of users 

and the use of additional contraceptive measures (barrier contraceptives). 

If you are about to undergo laboratory tests you must notify your doctor, since there may be 

changes in their results. 

If you are sensitive to any type of food or medicine, inform your doctor before commencing 

treatment with the medicine.

The medicine contains lactose monohydrate and sucrose.

DRUG INTERACTIONS:

If you are taking other drugs concomitantly or if you have just finished treatment with other 

medicines, including non-prescription medicines and food supplements, inform the attending 

doctor in order to prevent hazards or lack of efficacy arising from drug interactions. This is 

especially  important  for  medicines  belonging  to  the  following  groups:  antiepileptics  (e.g.: 

phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate), 

medicines  for  treatment  of  tuberculosis  (e.g.:  rifampicin,  rifabutin),  antibiotics  for  the 

treatment  of  infectious  diseases  (e.g.:  penicillin,  tetracycline,  griseofulvin  -  antifungal), 

medicines for treating AIDS-related infections (such as ritonavir), the herbal preparation St. 

John‘s wort ( hypericum, for treatment of depressive moods).

Some of these drugs may reduce the efficacy of this medicine as a contraceptive. Therefore, 

during concomitant use it is recommended to use an additional, non-hormonal, contraceptive 

method.

For further questions, consult your doctor.

SIDE EFFECTS:

In  addition  to  the  desired  effect  of  the  medicine,  adverse  reactions  may  occur  during  the 

course of treatment.

Common  side  effects:  nausea,  abdominal  pain,  weight  gain,  headache,  mood  changes/

depressive mood, breast pain or tenderness.

Uncommon  side  effects:  vomiting,  diarrhea,  fluid  retention,  migraine,  decreased  libido, 

enlargement of the breasts, rash, urticaria.

Rare  side  effects:  intolerance  to  contact  lenses,  hypersensitivity  reactions,  weight  loss, 

increased libido, vaginal discharge, discharge from the breasts, erythema nodosum, erythema 

multiforme.

These side effects usually disappear within a short time following the period of adaptation to 

the medicine. If they persist or become bothersome, refer to your doctor. 

Prolonged  use  of  the  medicine  may  sometimes  cause  brown  spots  on  the  skin  in  sensitive 

women. Prolonged exposure to sunlight may aggravate these spots. Therefore, women with 

such a tendency must avoid prolonged exposure to sunlight or to ultra-violet radiation. 

Effects that require special attention:

Stop taking the medicine immediately and consult your doctor in the following cases, which 

may be signs of thrombosis, of heart attack or of cerebrovascular accident: 

Unusual  cough,  sharp  chest  pain  radiating  to  the  left  arm,  sudden  shortness  of  breath  or 

difficulty breathing, migraine type headache occurring for the first time, any headaches that 

occur with unusual frequency or unusual intensity, any acute disturbances in vision, speech 

disorders, sudden changes in hearing, or in the sense of smell or taste, dizziness or fainting, a 

feeling of weakness or tingling in any part of the body, strong abdominal pains, unusual pain 

or swelling of the legs.

Further reasons to rapidly consult the doctor are: 

itching all over the body, increased frequency of epileptic seizures (involuntary movements), 

significant  increase  in  blood  pressure,  pregnancy  or  suspicion  of  pregnancy,  heavy  and 

unusual vaginal bleeding, severe diarrhea, in case you forgot to take the tablet in the first 

week  and  had  sexual  intercourse  during  the  preceding  week (during  the  tablet-free  week), 

four  weeks  before  planned  surgery  or  during  periods  of  immobility,  for  example:  after  an 

accident. 

In  the  event  that  you  experience  side  effects  not  mentioned  in  this  leaflet,  or  if  there  is  a 

change in your general health, consult your doctor immediately.

DOSAGE AND INSTRUCTIONS FOR USE:

A package of  Meliane contains 21 tablets. The day of the week and an arrow indicating in 

which direction to proceed are marked on the pack above each tablet. Take the tablet whole 

with  water  as  needed,  each  day  at  the  scheduled  hour.  Do  not  chew  the  tablet.  Take  the 

tablets according to the direction of the arrows until the package is finished.

After 21 days of taking the tablets, take a 7 day intermission. During these 7 intermission 

days  menstrual  bleeding  should  occur,  usually  2-3  days  after  taking  the  last  tablet.  Start 

taking  the  tablets  from  the  next  package  on  the  eighth  day,  even  if  menstrual  bleeding 

continues. 

In this way you will start a new package each month on the same day of the week.

Taking Meliane for the first time: 

Take the first tablet on the first day of menstrual bleeding. Take the tablet marked with the 

appropriate day of the week. 

Continue taking the tablets according to the direction of the arrows until the pack is finished. 

You are protected from pregnancy immediately. You can even begin taking the tablets between 

the second to fifth day of menstrual bleeding, but in this case you must use an additional 

method of contraception during the first 7 days of the first month of taking the pill.

Changing from another combined pill to Meliane:

Start taking  Meliane the first day after you finish taking the other oral contraceptive pill (i.e. 

there is no intermission between taking the pills). If your present package contains inactive 

tablets, start taking  Meliane the day after taking the last active tablet (if you are not sure 

what an active tablet is, consult your doctor or pharmacist).

Changing from a progestogen only pill to Meliane: 

Start on the first day of menstrual bleeding.

After delivery: The doctor will generally advise you to wait until after the first period before 

starting to use  Meliane.

After abortion/curettage: Consult your doctor.

HOW CAN YOU CONTRIBUTE TO THE SUCCESS OF THE TREATMENT?

If you forgot to take one or more Meliane tablets:

A less than 12-hour delay in taking one tablet:

If you forgot to take  Meliane, take the tablet as quickly as possible and continue taking the 

rest of the tablets as usual in the direction of the arrow. Your protection from pregnancy has 

not been impaired.

A delay of more than 12 hours in taking one tablet:

If more than 12 hours have elapsed take the missed tablet as soon as you remember, then 

continue taking the rest of the tablets as usual, even if this means taking 2 tablets on the 

same day. Concurrently, you should use an additional contraceptive method (for instance, a 

condom, spermicide, etc.) for the next 7 days.

Additionally,  if  you  forgot  to  take  the  tablet  during  the  last  7  days,  finish  the  pack  and 

continue  with  the  next  pack  without  any  break.  If  no  bleeding  occurs  after  finishing  the 

second pack, consult your doctor before you resume taking the tablets.

If you forgot to take more than one  Meliane tablet, consult your doctor.

Efficacy in cases of vomiting or diarrhea:

Mild laxatives do not reduce the reliability of the pill. However, if you suffer from a stomach 

upset leading to severe vomiting or diarrhea, there is no absolute guarantee that the daily 

tablet will be totally absorbed from the gastrointestinal tract. If vomiting occurs within 3-4 

hours after taking the tablet, the situation is similar to having forgotten to take the tablet; 

therefore, follow the directions given for such a situation. 

If you have severe diarrhea, consult your doctor.

If bleeding occurs in between cycles:

During the first months breakthrough bleeding (spotting or light bleeding) may occur. This 

breakthrough  bleeding  will  generally  stop  once  your  body  adapts  to  the  use  of  the  pill 

(usually  after  three  cycles  of  taking  the  pill).  Therefore,  continue  taking  the  tablets.  If 

bleeding  is  heavy,  persistent  or  recurs  refer  to  your  doctor.  If  menstrual  bleeding  does  not 

occur refer to your doctor immediately in order to rule out the possibility of pregnancy. In any 

case, do not start a new series of tablets without consulting the doctor.

AVOID POISONING!

This  medicine  and  all  other  medicines,  must  be  stored  in  a  safe  place  out  of  the  reach  of 

children and/or infants, to avoid poisoning. If you have taken an overdose, or if a child has 

accidentally swallowed the preparation, proceed immediately to a hospital emergency room 

and bring the package of the medicine with you.

Do not induce vomiting unless explicitly instructed to do so by a doctor! 

This  medicine  has  been  personally  prescribed  for  you  as  an  oral  contraceptive,  in  another 

women  it  may  cause  harm.  Do  not  give  this  medicine  to  your  relatives,  neighbours  or 

acquaintances.   Do not take medicines in the dark! Check the label and the dose each time 

you take this medicine. Wear glasses if you need them.

STORAGE: 

Do not store at a temperature above 25°C. Protect from light.

Even if kept in their original container and stored as recommended, medicines may be kept for 

a limited period only. Please note the expiry date of the medicine! In case of doubt, consult the 

pharmacist who dispensed the preparation to you.

Do not store different medications in the same package.

LICENSE NUMBER: 109 12 29094 00

MANUFACTURER: Delpharm Lille S.A.S., Lys Lez Lannoy, France.

REGISTRATION HOLDER: Bayer Israel Ltd., 

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

The dispensing of this medicine requires a doctor‘s prescription

Read this package insert carefully in its entirety before using this medicine 

The format of this leaflet was determined by the Ministry of Health and its content was checked and approved by it in August 2010

Meliane®

Coated Tablets

Layout Management AM   Seite  2  Bayer Schering Pharma

Mandant:  534   Stof f-Nr .:  64013113   PZ:  2613A-3   Code-Nr .:  20

Bezeichnung:  Meliane 1x21,  3x21   Aufmachung:  Israel BSP

Farben:  Black

Version:  25.11.2008/01   Freigabe:

1986 - ו"משתה )םירישכת( םיחקורה תונקת יפל תינכרצל ןולע

אפור םשרמב תבייח וז הפורת

הפורתב ישמתשת םרטב ופוס דע ןולעה תא ןויעב יארק

2010 טסוגואב ודי-לע רשואו קדבנ ונכותו תואירבה דרשמ ידי-לע עבקנ הז ןולע טמרופ

:בכרה

:הליכמ הילבט לכ

Gestodene        0.075 mg

Ethinylestradiol 0.020 mg

:םיליעפ יתלב םירמוח

Lactose  monohydrate,  maize  starch,  povidone  25000,  magnesium  stearate,  sucrose, 

povidone  700000,  polyethylene  glycol  6000,  calcium  carbonate,  talc,  montanglycol  wax 

(wax E).  

.טארדיהונומ זוטקל ג"מ 37.15 :הליכמ הילבט לכ

.זורכוס ג"מ 19.66 :הליכמ הילבט לכ

 .)ןגוטסגורפו ןגורטסא( ןוירה תעינמל תבלושמ הלולג :תיטיופרת הצובק

.ןוירה תעינמל הלולג :תיאופר תוליעפ

?רישכתב שמתשהל ןיא יתמ

.ןוירהל ששח םייק םא וא ןוירהב ךניה רשאכ הפורתב ישמתשת לא

.הפורתה יביכרממ דחאל תושיגר ךל העודי םא שמתשהל ןיא

 :םיאבה םיבצמב ,ןאילמ ןוגכ ,ןוירה תעינמל תבלושמ הלולג לוטיל ןיא

 םיכילהתב דחוימב ,םדה רוזחמ לע העיפשמה הלחממ רבעב תלבס וא תלבוס ךניה םא

 תקקפ( םיילגרה לש םדה ילכב רצוויהל םילולעש )םד שירק תורצוויה - תקקפ( םייטובמורת

 האצותכ  יחומ  עוריא(  חומב  ,)בל  ףקתה(  בלב  ,)תואיר  ףיחסת(  תואירב  ,)םיקומע  םידירו

 .ףוגה לש םירחא םיקלחב וא )םומיד וא םד שירקמ

 וא  סירוטקפ  הניגנא  ןוגכ(  בל  ףקתהל  ןושאר  ןמיס  םיווהמה  ,הווהב  וא  רבעב  ,םירקמב

 לש הירוטסיה .)ךיפה לק ץבש וא ףלוח ימכסיא ףקתה ןוגכ( יחומ עוריאל וא )הזחב םיבאכ

 יקלחמ דחאב לומינ תשוחת/השלוח וא רובידב תוערפה ,הייארב תוערפהב הוולמה הנרגימ

 בלבלב תקלד לש ,הווהב וא רבעב ,םירקמב ,םדה ילכל קזנ םע תרכוס לש םירקמב ,ףוגה

 דבכ תלחמ וא תבהצ לש םירקמב ,םדב םינמוש לש תוהובג תומרב הוולמה )סיטיטארקנפ(

 ןטרס וא דשה ןטרס ןוגכ( םינומרוה יולת ינטרס לודיג לש ,הווהב וא רבעב ,םירקמב ,הפירח

 )ילאניגו( יקיתרנ םומיד ,הווהב וא רבעב דבכב םיריאממ וא םיריפש םילודיג ,)הייברה ירביא לש

 לש הירוטסיה ,םינמושה לש םזילובטמב תוערפה ,( Sickle Cell ) תישמרח הימנא ,רבסומ אל

 .ןוירה ןמזב תבהצ ,ףוגה לכב דוריג ,ןוירהה ךשמב )סיזורלקסוטוא( ןזואה תשרט תרמחה

 שומישה תא קיספהל שי ,הפורתב שומישה תעב הנושארל עיפומ ל“נה םירקמהמ דחא םא

.םיילנומרוה אל העינמ יעצמאב שמתשהל שי םייתניב .לפטמה אפורה םע ץעייתהלו

:לופיטה תלחתה ינפל אפורב ץעוויהל ילבמ הפורתב שמתשהל ןיא

 .הקינמ ךניה םא

 ןיקת אל םתסמ - בלה דוקפתב יוקילמ רבעב תלבס וא תלבוס ךניה םא ,תנשעמ ךניה םא

 תא םא ןכ ומכ ,ןתשה תכרעמ/הילכה ,הרמה סיכ וא )תבהצ( דבכה ,בלה בצקב הערפה וא

 ,םיילגרב תוילד ,רתי לקשמ ,תרכוס ,םד ץחל רתי :תואבה תולחמה תחאמ תלבס וא תלבוס

 ןויפכ ,הנרגימ ,יחומ עוריא וא בל ףקתה ,הזובמורת לש תיתחפשמ הירוטסיה ,םידירו תקלד

 הירוטסיה  תמייק  םא  םג(  םדב  םידירצילגירט  וא  לורטסלוכ  לש  תוהובג  תומר  ,)היספליפא(

 ,סגה יעמה לש תיביכ תקלד ,ןורק תלחמ ,דשה ןטרס לש תיתחפשמ הירוטסיה ,)תיתחפשמ

 הנושארל ועיפוהש תועפות ,תימרוא תיטילומה תנומסת ,)סופול( תיתכרעמ תיתנמדא תבאז

 ,ןוירהב  ספרה  לש  הירוטסיה  ,היריפרופ  ןוגכ  םינומרוה  תליטנ  וא  ןוירה  ךלהמב  ורימחה  וא

 ,)םינפב דחוימב ,רועה לע היצטנמגיפ ימתכ( המזאולכ ,)תיבצע הלחמ(  Sydenham’s chorea

 .עגמ תושדעל תוליבס יא וא ,הצופנ תשרט ,ןואכיד

 שומישה  תעב  הרימחה  וא  בוש  העיפוה  ,הנושארל  העיפוה  תורכזנה  תועפותהמ  תחא  םא

.אפורב ץעוויהל ךיילע ,הפורתב

?ךלש םוי םויה ייח לע הפורתה עיפשת ךיא

 תליטנב תוברועמה ,םד ילכבו בלב תורושקה תויניצר יאוול תועפותלו םיקרוע תקקפל ןוכיסה

 לש  תולודג  תויומכ  תונשעמה  םישנב  הלוע  הז  ןוכיס  .ליגה  םע  הלוע  ,ןוירה  תעינמל  הלולג

.הפורתב שומישה ןמזב ןשעל אל ץלמומ ,ךכל יא .35 ליג לעמ ןה םא דחוימב ,תוירגיס

:תורהזא

 לכ וא סדייאה תלחמב תוקבדיה ינפמ הנגמ הניא ,ןוירה תעינמל הלולג לכ ומכ ,וז הפורת

.ינימ עגמב תרבעומה תרחא הלחמ

.ןוירהב ךניאש אדוולו הפיקמ תיגולוקינגו תיללכ הקידב רובעל שי לופיטה תלחתה ינפל

 הפוקתל  וז  הפורת  תלטונ  תא  םא  םג  ךכ  ,םיילנומרוה  םירישכתב  ךשוממ  שומישב  גוהנכ

 םג ץלמומ .תיתרגש תיגולוקינג הקידב םשל םישדוח 6 לכ ךאפור לצא רקבל ךיילע ,תכשוממ

.םישדוח 6 לכ םד ץחל תוקידב ךורעל

 םא םדה תשירק תכרעמב תוערפה לולשל שי .תיתחפשמה הירוטסיהל הדיפקב סחייתהל שי

 לש תקקפ ,אמגודל( תילובמא-ובמורת הלחממ לבס הנושאר הברקב החפשמה ינבמ והשימ

 .ריעצ ליגב )בלה רירש םטוא ,יחומ עוריא ,םיקומעה םידירוה

 שומיש ידכ ךות םידירו תקקפ תורצוויהל רתויב הובגה ןוכיסה .הרידנ העפות איה םידירו תקקפ

 .הנושארה שומישה תנש ךלהמב וניה ןוירה תעינמל הלולגב

 הלולע  איה  ,ןוירה  תעינמל  הלולג  תלטונ  ךניאש  הדימב  םג  חתפתהל  הלוכי  םידירו  תקקפ

 תושמתשמה  ברקב  רתוי  הובג  םידירו  תקקפל  ןוכיסה  .ןוירהל  תסנכנ  ךניה  םא  םג  תורקל

.ןוירה ןמזב ןוכיסה ומכ הובג וניא ךא ,תושמתשמ ןניאש הלא תמועל הלולגב

 וא תוילכב ,םייעמב ,דבכב עיפוהל םילולע םד ישירק ,רתויב םירידנ םירקמב .)ץבשל םורגל(

.תוומל ףא וא םיידוקפת םייוקילל םורגל הלולע תקקפ םיתיעל .םייניעב

 ךיילע  םא  ןכל  ,העונת  רסוח  לש  תופוקתב  וא  םיחותינ  רחאל  תינמז  הלוע  תקקפל  ןוכיסה

 תועובש 4 תוחפל הלולגב שומישה יבגל ךאפור תא עדייל ךיילע ,זפשאתהל וא חותינ רובעל

 תא קיספהל יצלאתש ןכתיי ,הפורתב שומישה תעב םד ץחל רתי ךלצא חתפתי םא .שארמ

.הב שומישה

 דשה ןטרס לש םירקמ רתוי טעמ ונחבוא ןוירה תעינמל הלולגב תושמתשמה םישנ ברקב

 םינוחבאה רפסמב וז הנטק היילע .הלולגב תושמתשמ ןניאש ליגה ותואב םישנ ברקב רשאמ

.הלולגה תליטנ תקספה רחאלש םינש 10 ךשמב הגרדהב תמלענ דשה ןטרס לש

 וקדבנ  ולא  םישנש  הדבועהש  ןכתיי  .הלולגב  שומישהמ  האצותכ  םרגנ  לדבהה  םא  עודי  אל

.דשה ןטרס לש רתוי תמדקומ הנחבאל האיבה רתוי תובורק םיתיעל

 םיריאממ םילודיג ופצנ רתוי םירידנ םירקמבו ,דבכה לש םיריפש םילודיג ופצנ םירידנ םירקמב

 .ןוירה תעינמל הלולגב שומיש רחאל ,ןכוסמ ינטב ךות םומידל םידדוב םירקמב וליבוהש ,דבכב

 םמצעמ םימלענ םניא רשא הנוילעה ןטבב םיקזח םיבאכ תעפוה לע אפורל עידוהל שי ,ןכל

.רצק ןמז ךות

   ידי-לע  םרגנה  ךשמתמ  ילאריו  םוהיז  אוה  םחרה  ראווצ  ןטרסל  רתויב  בושחה  ןוכיסה  םרוג

 םורתל  לולע  ןמז  ךרואל  הלולגב  שומישש  וארה  םירקחמ  רפסמ  . human   papillomavirus

 ,םירחא םימרוגל םג םירושק הלא םיאצממ םאה תקולחמ ןיידע תמייק םלוא ,ןוכיסה תרבגהל

 םיפסונ  העינמ  יעצמאב  שומישהו  תושמתשמה  לש  ןימה  ילגרה  ,םחרה  ראווצ  תוקידב  ןוגכ

barrier contraceptives (

 םייוניש םרגיהל םילולעש ןוויכ ,אפורל חוודל ךיילע תויתדבעמ תוקידב רובעל תדמוע ךניה םא

.ןהיתואצותב

 תליטנ ינפל אפורל ךכ-לע עידוהל ךיילע ,יהשלכ הפורתל וא והשלכ ןוזמל השיגר ךניה םא

.הפורתה

.זורכוסו טארדיהונומ זוטקל הליכמ הפורתה

 :תויתפורת-ןיב תובוגת

 תופורת ללוכ ,תורחא תופורתב לופיט התע הז תרמג םא וא ,תופסונ תופורת תלטונ ךניה םא

-יא וא םינוכיס עונמל ידכ לפטמה אפורל חוודל ךיילע ,הנוזת יפסותו םשרמ אלל תורכמנה

 תופורת :תואבה תוצובקהמ תופורת יבגל דחוימב ,תויתפורת-ןיב תובוגתמ םיעבונה תוליעי

 ,ןיפזברקסקוא ,ןיפזמאברק ,ןודימירפ ,םיטרוטיברב ,ןיאוטינפ :ןוגכ( )היספליפא( ןויפכב לופיטל

 תוקיטויביטנא ,)ןיטובאפיר ,ןיציפמאפיר :ןוגכ( תפחשב לופיטל תופורת ,)טאמבלפ ,טמריפוט

 לופיטל תופורת ,)תוירטפ דגנ - ןיבלופואסירג ,ןילקיצרטט ,ןיליצינפ :ןוגכ( תוימוהיז תולחמל

 ,םוקירפיה(  St. John’s wort  יחמצה רישכתה ,)ריואנוטיר :ןוגכ( סדייאה תלחמ לש םימוהיזב

.)םיינואכיד חור יבצמב לופיטל

-וב שומישב ,ןכל .ןוירה תעינמב וז הפורת לש התוליעי תא ןיטקהל לולע ולא תופורתמ קלח

 .ןוירה תעינמל ,תילנומרוה אל ,תפסונ הטיש ףיסוהל ץלמומ ינמז

.אפורל תונפל שי ,תופסונ תולאשל

 :יאוול תועפות

 .יאוול תועפות עיפוהל תולולע הב שומישה ןמזב ,הפורתה לש היוצרה תוליעפל ףסונב

 בצמב  םייוניש  ,שאר  באכ  ,ףוגה  לקשמב  היילע  ,ןטב  באכ  ,הליחב  :תוחיכש יאוול תועפות

.םיידשב תושיגר וא באכ ,ינואכד חור בצמ/חורה

 תלדגה ,ינימה ףחדב הדירי ,הנרגימ ,םילזונ תריגא ,לושלש ,האקה :תוחיכש אל יאוול תועפות

.)הירקיטרוא( תדפרס ,החירפ ,םיידשה

 היילע ,לקשמב הדירי ,רתי תושיגר לש תובוגת ,עגמ תושדעל תוליבס יא :תורידנ יאוול תועפות

.םרופיטלומ המתירא ,םוזודונ המתירא ,םיידשהמ תושרפה ,תוילאניגו תושרפה ,ינימה ףחדב

 תועפות םא .הפורתל תולגתסהה תפוקת רחאל רצק ןמז ךות ללכ-ךרדב תופלוח ולא תועפות

.אפורל תונפל שי תודירטמ וא תוכשמנ ולא

 םישנ  לצא  רועה  לע  םימוח  םימתכ  תעפוהל  םיתיעל  םורגל  לולע  הפורתב  ךשוממ  שומיש

 םע םישנ לע ןכל .שמשל תכשוממ הפישח בקע רימחהל םייושע הלא םימתכ .ךכל תושיגרה

.הלוגס הרטלוא הנירקל וא שמשל תכשוממ הפישחמ ענמיהל וזכ הייטנ

:תדחוימ תוסחייתה תובייחמה תועפות

 םינמיס תויהל םילוכיש ,םיאבה םירקמב אפורב ץעוויהלו דימ הפורתה תליטנ תא קיספהל שי

:יחומ עוריאל וא בל ףקתהל ,תקקפל

 המישנ יישק וא רצוק ,לאמש דיל ןירקמה הזחב ףירח באכ לש השוחת ,ליגר יתלב לועיש

 שאר  באכ  לש  הרקמ  לכ  ,הנושארה  םעפב  הנרגימ  גוסמ  שאר  יבאכ  תעפוה  ,םיימואתפ

 ,הייארב הפירח הערפה לש הרקמ לכ ,הליגר אל המצועב וא הליגר אל תופיכתב עיפומה

 ,ןופליע וא תרוחרחס ,םעטה וא חירה שוחב וא העימשב םיימואתפ םייוניש ,רובידב תוערפה

 םיליגר אל םיבאכ ,םיזע ןטב יבאכ ,ףוגה יקלחמ דחאב )םיצוצקיע( לומינ וא השלוח תשוחת

.םיילגרה לש תוחפנתה וא

 :ןה םדקהב אפורל היינפל תופסונ תוביס

 תיפיגנ  דבכ  תקלד  ,)בוהצל  רוע  ןווג  יוניש(  תבהצ  תעפוה  ,דשב  שוג  השיגרמ  ךניה  םא

 ,םייטפליפא )תוינוצר יתלב תועונת( םיסוכריפ תוחיכשב היילע ,ףוגה לכב דרג ,)סיטיטאפה(

 לושלש ,ליגר יתלבו דבכ ילאניגו םומיד ,ןוירהל דשח וא ןוירה ,םדה ץחלב תיתועמשמ היילע

 עובשב( ןכ ינפל עובשב ןימ יסחי תמייקו ןושארה עובשב הילבט לוטיל תחכשש הרקמב ,רומח

 ,העונת רסוח לש תופוקתבו ןנכותמ חותינ ינפל תועובש העברא ,)תוילבטה תליטנ תקספה

 ךתשגרהב יוניש לח םא וא ,הז ןולעב וניוצ אלש יאוול תועפות השיגרמ ךניה ובש הרקמ לכב

.דימ אפורה םע ץעייתהל ךיילע תיללכה

:שומישה ןפואו ןונימ

 החנמה ץחו עובשב םויה םיניוצמ הילבט לכ בגב ,הסיפחה יבג לע .תוילבט 21 ןאילמ תזיראב

 ידמ ,ךרוצה יפל םימ תפסותב התומלשב הילבטה תא לוטיל ךיילע .תומדקתהה ןוויכב ךתוא

 םויסל דע םיציחה ןוויכל םאתהב תוילבטה תא ילט .הילבטה תא סועלל ןיא .העובק העשב םוי

 .הזיראה

 עיפוי הקספהה ימי 7 ךלהמב .םימי 7 תב הקספה יכרע ,תוילבטה תליטנ לש םימי 21 רחאל

 תליטנב  יליחתה  .הנורחאה  הילבטה  תליטנ  רחאל  השולש-םיימוי  ללכ-ךרדב  ,תסווה  םומיד

 .ךשמנ יתסיווה םומידה םא םג ,ינימשה םויב האבה הזיראהמ תוילבט

.עובשב םוי ותואב השדח הזירא שדוח לכב יליחתת הז ןפואב

:הנושארה םעפב ןאילמ תליטנ

 תנמוסמה הילבטה תא ילט .תסווה םומיד לש ןושארה םויב הנושארה הילבטה תא לוטיל ךיילע

.עובשב םיאתמה םויב

 ןוירה ינפמ תנגומ ךניה .הסיפחה םויסל דע םיציחה ןוויכל םאתהב תוילבטה תא לוטיל יכישמה

 םומיד לש ישימחל ינשה םויה ןיב םג תוילבטה תא לוטיל ליחתהל הלוכי תא .ידיימ ןפואב

 לש םינושארה םימיה 7 -ב ףסונ העינמ יעצמאב שמתשהל ךיילע הז הרקמב םלוא ,תסווה

.הלולגה תליטנל ןושארה שדוחה

:ןאילמל תרחא תבלושמ הלולגמ רבעמ

 ,רמולכ( ןוירה תעינמל תרחאה הלולגה תא לוטיל תמייסש רחאל םוי ןאילמ לוטיל ליחתהל שי

 יליחתה ,תוליעפ אל תוילבט הליכמ ךלש תיחכונה הסיפחה םא .)תולולגה תליטנב הקספה ןיא

 הילבטה יהמ החוטב ךניא םא( הנורחאה הליעפה הילבטה תליטנ רחאלש םויב ןאילמ לוטיל

.)חקורב וא אפורב יצעוויה ,הליעפה

:ןאילמל דבלב ןגוטסגורפ תלולגמ רבעמ

.םומידה לש ןושארה םויב ליחתהל שי

 תליחת  ינפל  הנושארה  תסווה  רחאל  דע  תוכחל  ללכ-ךרדב  ךל  ץעיי  אפורה  :הדיל  רחאל

.ןאילמב שומישה

.אפורב יצעוויה :הדירג/הלפה רחאל

?לופיטה תחלצהל עייסל ילכות דציכ

:ןאילמ לש רתוי וא תחא הילבט לוטיל תחכשש הדימב

:תחא הילבט תליטנב תועש 12 -מ ןטק בוכיע

 ראש  תליטנב  יכישמהו  ןתינש  לככ  רהמ  הילבטה  תא  ילט  ,ןאילמ  לוטיל  תחכשש  הדימב

.העגפנ אל ןוירה ינפמ ךתנגה .ץחה ןוויכב ליגרכ תוילבטה

:תחא הילבט תליטנב תועש 12 לע הלועה בוכיע

 תא לוטיל יכישמהו תרכזנשכ דימ הנורחאה הילבטה תא ילט תועש 12 -מ רתוי ורבע םא

 שי ןמז ותואב .םוי ותואב תוילבט 2 תליטנ איה תועמשמה םא וליפא ,ליגרכ תוילבטה ראש

.םיאבה םימיה 7 ךשמב )‘וכו ערז לטוק ,םודנוק לשמל( ףסונ העינמ יעצמאב שמתשהל

 ךישמהלו הסיפחה תא םייסל שי ,םינורחאה םימיה 7 -ב הילבטה תא לוטיל תחכש םא ,ףסונב

 ץעוויהל שי ,הינשה הסיפחה רחאל םומיד עיפוי אלש הדימב .הקספה אלל האבה הסיפחב

.תוילבטה תליטנ תא שדחמ הליחתמ תאש ינפל אפורב

.לפטמה אפורב ץעוויהל ךיילע ,ןאילמ לש תחא הילבטמ רתוי לוטיל תחכשש הדימב

:לושלש וא האקה לש הרקמב תוליעי

 םרוגה הביק לוקלקמ תלבוס תא םא ,םלוא .הלולגה תוליעי תא םיניטקמ םניא םילק םילשלשמ

 התומלשב  גפסית  תימויה  הילבטהש  תטלחומ  הבורע  ןיא  ,םיפירח  םילושלשל  וא  תואקהל

 המוד בצמה ,הילבטה תליטנ רחאלש תועש 3-4 ךותב תואקה לש הרקמב .לוכיעה תכרעממ

 .הז בצמל הנתינש היחנהה יפל יגהנ ןכל ,הילבט לוטיל תחכש וב הרקמל

.לפטמה אפורה םע ץעוויהל שי ,רומח לושלשהש הדימב

:יתסיוו-ןיב םומיד תעפוה

 .)לק  םומיד  וא  םימתכ(  םייתסיוו-ןיב  םימומיד  עיפוהל  םילולע  םינושארה  םישדוחה  ךשמב

 רחאל ללכ-ךרדב( הלולגב שומישל לגתסי ךפוגש רחאל ללכ-ךרדב קספיי הז יתסיוו-ןיב םומיד

 וא ךשוממ ,דבכ םומידהש הדימב .תוילבטה תא לוטיל יכישמה ןכל ,)הלולגה תליטנ ירוזחמ 3

.אפורל ינפ ,שדחתמ

 .ןוירה לש תורשפא לולשל תנמ-לע ךאפורל דימ תונפל ךיילע יתסיוו םומיד עיפוה אלש הרקמב

.אפור םע תוצעייתה אלל השדח תוילבט תרדסב לופיט ליחתהל ןיא ,הרקמ לכב

 !הלערה יענמ

 תוקונית וא/ו םידלי לש םדי גשיהל ץוחמ רוגס םוקמב רומשל שי תרחא הפורת לכו וז הפורת

.הלערה יענמת ךכ ידי-לעו

 םילוח-תיב לש ןוימ רדחל דימ ינפ ,הפורתה ןמ דלי עלב תועטב םא וא רתי תנמ תלטנ םא

.ךתיא הפורתה תזירא יאיבהו

!אפורמ תשרופמ הארוה אלל האקהל ימרגת לא

 ינתית לא .קיזהל הלולע איה תרחא השיאל ,ןוירה תעינמל ךרובע תישיא המשרנ וז הפורת

.ךיירכמ וא ךיינכש ,ךייבורקל וז הפורת

 יביכרה .וז הפורת תלטונ ךניהש םעפ לכב הנמהו תיוותה יקדב !ךשוחב תופורת לוטיל ןיא

.םהל הקוקז ךניה םא םייפקשמ

 :הנסחא

.רוא ינפמ ןגהל שי .25 ° C לע הלועה הרוטרפמטב ןסחאל ןיא

 אנ  .דבלב  תלבגומ  הפוקתל  תורמשנ  תופורת  ,םיצלמומה  הנסחאה/הזיראה  יאנת  יפל  םג

 קפיסש חקורב ץעוויהל ךיילע ,קפס לש הרקמ לכב !רישכתה לש הגופתה ךיראתל בל םישל

 .הפורתה תא ךל

.הזירא התואב תונוש תופורת ןסחאל ןיא

 109 12 29094 00 :הפורתה םושיר 'סמ

.תפרצ , Lys Lez Lannoy  ,.ס.א.ס ליל םראפלד :ןרצי

 :םושירה לעב

 ,מ"עב לארשי רייאב

ןאילמ

תופוצמ תוילבט

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch, because it may contain undeclared milk and soy. This only effects products with Lot number PL: 0100518 Exp: 04/2020. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Published on: Tue, 04 Sep 2018 00:00:00 +0200 This technical report reflects the outcome of the mammalian toxicology experts meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. The main issues identified were related to genotoxicity of products and principles of (Q)SAR and read‐across. General presentations on the different EFSA guidance and EFSA developmental activities related to human health risk assessment of pesti...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Denmark and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 This report describes the framework of collection, management and transmission of food safety data in the Federal Republic of Germany. To adjust optimally the data governance processes to the requirements defined by the EFSA, measures had been agreed upon in order to improve the specified situation. Subsequent methodological system enhancements related to data quality are given as well as structural adjustments and the development and implementation of suppo...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

6-7-2018

Bekrachtiging besluit tot zelfstandige bevoegdheden voor mondhygiënisten

Bekrachtiging besluit tot zelfstandige bevoegdheden voor mondhygiënisten

De ministerraad heeft ingestemd met het besluit van minister Bruins voor Medische zorg om mondhygiënisten vanaf 1 januari 2020 zelfstandige bevoegdheden te geven. Het gaat om een  experiment voor een periode van vijf jaar. Ze mogen zelfstandig verdoven, röntgenfoto’s maken en eerste gaatjes vullen.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-8-2018

BYDUREON (AstraZeneca AB)

BYDUREON (AstraZeneca AB)

BYDUREON (Active substance: exenatide) - Centralised - Variation - Commission Decision (2018)5776 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2020/X/48/G

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety