Source: US Department of Health and Human Services
CMS has two senior Agency veterans – one focused on policy and one focused on operations – who are leading the collaboration with DOGE, including ensuring appropriate access to CMS systems and technology. We are taking a thoughtful approach to see where there may be opportunities for more effective and efficient use of resources in line with meeting the goals of President Trump.
Source: NASA
This Feb. 5, 1971, photo gives an excellent view of the Apollo 14 lunar module on the Moon’s surface after landing. At left, we can see that the astronauts – Alan Shepard and Edgar Mitchell – deployed the U.S. flag before taking this photo of the lunar module.
Shepard and Mitchell touched down in the Fra Mauro highlands region and conducted two moonwalks lasting more than nine hours in total. They set up an experiment package and collected 93 pounds of rock and soil samples to return to waiting scientists on Earth. In the meantime, astronaut Stuart Roosa, who remained in orbit aboard the command module, conducted observations and photography of the lunar surface from orbit. After their 33-hour lunar surface stay, Shepard and Mitchell rejoined Roosa in orbit, and left lunar orbit for the three-day return trip to Earth.
Image credit: NASA
Source: NASA
For the first time, NASA is hosting a live Twitch event from about 250 miles off the Earth aboard the International Space Station, bringing new audiences closer to space than ever before. Viewers will have the opportunity to hear from NASA astronauts live and ask questions about life in orbit.
The event will begin at 11:45 a.m. EST on Wednesday, Feb. 12, livestreamed on the agency’s official Twitch channel:
https://www.twitch.tv/nasa
“This Twitch event from space is the first of many,” said Brittany Brown, director, Office of Communications Digital and Technology Division, at NASA Headquarters in Washington. “We spoke with digital creators at TwitchCon about their desire for streams designed with their communities in mind, and we listened. In addition to our spacewalks, launches, and landings, we’ll host more Twitch-exclusive streams like this one. Twitch is one of the many digital platforms we use to reach new audiences and get them excited about all things space.”
Although NASA has streamed events to Twitch previously, this conversation will be the first NASA event from the International Space Station developed specifically for the agency’s Twitch platform.
During the event, viewers will hear from NASA astronaut Don Pettit, who is currently aboard the orbiting laboratory, and NASA astronaut Matt Dominick, who recently returned to Earth after the agency’s Crew-8 mission.
The NASA astronauts will discuss daily life aboard the space station and the research conducted in microgravity. Additionally, the event will highlight ways for Twitch users to engage with NASA, including citizen science projects and science, technology, engineering, and math programs designed to inspire the Artemis Generation.
NASA is committed to exploring new digital platforms to engage with new audiences. Last year, the agency introduced its own streaming platform, NASA+, and redesigned nasa.gov and science.nasa.gov websites, creating a new homebase for agency news, Artemis information, and more.
To keep up with the latest news from NASA and learn more about the agency, visit:
Home Page
-end-
Abbey DonaldsonHeadquarters, Washington202-358-1600Abbey.a.donaldson@nasa.gov
Source: US Food and Drug Administration
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“FDA approved!”
Maybe you saw those words on a company’s website or in a commercial promoting a product or treatment. Some marketers may say their products are “FDA approved.” But how can you know for sure what the U.S. Food and Drug Administration has approved?
The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.
But not all those products undergo premarket approval — that is, a review of safety, quality, and effectiveness by FDA experts and agency approval before a product can be sold to consumers. In some cases, the FDA’s enforcement efforts focus on products after they are already for sale. That is determined by Congress in establishing the FDA’s authorities. Even when FDA approval is not required before a product is sold, the agency has legal regulatory authority to act when safety issues arise.
Here is a guide to how the FDA regulates products for people — and what the agency does (and doesn’t) approve.
The FDA does not “approve” health care providers, including physician offices, or laboratories. The FDA does have authority to inspect regulated facilities to verify that they comply with current good manufacturing practices.
Although manufacturing facilities and contract manufacturers are often inspected as part of a product application for certain products that require premarket approval, the agency does not approve manufacturing facilities independently. The FDA does have authority to inspect regulated facilities to verify that they comply with applicable current good manufacturing practices and other requirements, including an adequately designed and controlled production process.
Unless an exemption applies, owners and operators of domestic or foreign food, drug, and most device facilities must register with the FDA before exporting products to the U.S. Owners and operators of establishments that manufacture blood products or cells, tissues, and cellular and tissue-based products must also register with the agency.
Mammography facilities must be FDA-certified and must display their FDA certificates where patients can see them. The certificate indicates that the facilities have met stringent standards for providing quality mammography.
New drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.
Some examples of biological products that require approval are therapeutic proteins, vaccines, allergenic products, cellular and gene therapies, and products manufactured from plasma. Manufacturers must also prove that they are able to make the drug or biological product according to federal quality standards.
The FDA does not develop products before approving them. Instead, FDA experts conduct a careful evaluation of the results of laboratory, animal, and human clinical testing done by manufacturers. The FDA does perform lot release testing of many biological products, which provides the agency with a real-time system to continuously monitor product quality, through review and testing.
For more information, see:
Compounding is generally a practice in which a pharmacist or a doctor combines ingredients to create medications that meet the needs of individual patients, including those who are allergic to ingredients in FDA-approved medicines or who cannot swallow an FDA-approved pill.
Be aware that compounded drugs are not FDA approved.
This means that the FDA does not conduct premarket review for compounded drugs to evaluate their safety, effectiveness, or quality.
The FDA classifies devices according to risk and the level of regulatory controls needed to provide a reasonable assurance of the safety and effectiveness of the devices. The highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application before marketing. To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.
Generally, the FDA “clears” moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval. Class II devices are generally subject to special controls, which may include specific testing or labeling requirements for that device.
Devices that are low risk of harm to the user (Class I) (for example non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves) are subject to general controls only, and most are exempt from premarket notification requirements.
All human cells and tissues intended for use in people — collectively referred to as human cells, tissues, and cellular and tissue-based products (HCT/Ps) — are regulated to prevent the transmission of infectious disease. Examples of HCT/Ps include bone, skin, corneas, ligaments, tendons, dura mater, heart valves, and reproductive tissue.
Those HCT/Ps that pose an additional risk because of their processing or use also require FDA approval before marketing.
The FDA does not regulate the transplantation of vascularized human organ transplants such as kidney, liver, heart, lung, or pancreas. The Health Resources Services Administration (HRSA) oversees the transplantation of vascularized human organs.
There’s no such thing as a safe tobacco product, so the FDA’s safe and effective standard for evaluating medical products does not apply to tobacco products. Instead, the FDA regulates tobacco products based on a public health standard that considers the product’s risks to the population, including users and nonusers of tobacco products.
To legally sell or distribute a new tobacco product in the U.S., manufacturers must receive authorization from the FDA. There are three pathways available to bring a new tobacco product to market: premarket tobacco product applications, substantial equivalence applications, or exemption from substantial equivalence requests.
A marketing authorization does not indicate that the tobacco product is either safe or “approved.” It means that the manufacturer has complied with the requirements under the law to bring its product to market.
Although the FDA does not have premarket approval of food products, it has the authority to approve certain ingredients before they are used in food or intended to contact food. Those include food additives (substances added intentionally to food, as well as substances that migrate to food from food contact products such as food packaging), and color additives.
Companies that want to add new food additives to food are responsible for providing the FDA with information demonstrating that the additives are safe. FDA experts review the results of appropriate tests done by companies to ensure that the food additive is safe for its intended use. An approved food additive must be used in compliance with its approved uses, specifications, and restrictions.
Certain food ingredients, such as those that are considered “generally recognized as safe” (GRAS) for their intended conditions of use by scientific experts, do not require premarket approval by the FDA. The FDA has a voluntary notification process under which a manufacturer may submit a conclusion that the use of an ingredient is GRAS.
This includes those used in food (including animal food), dietary supplements, drugs, cosmetics, and some medical devices. These color additives (except coal-tar hair dyes) are subject by law to approval by the agency before market entry, and each must be used only in compliance with its approved uses, specifications, and restrictions.
In the approval process, the FDA evaluates safety data to ensure that a color additive is safe for its intended purposes.
Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients, and their labeling, do not require FDA approval.
There’s one exception: color additives (other than coal-tar hair dyes). Cosmetics must be safe for their intended use and properly labeled.
A medical food is formulated to be consumed or administered enterally and intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. An example of a disease or condition that a medical food could be used to manage is phenylketonuria, a genetic disorder. Someone with this disorder may need medical foods that are formulated to be free of the amino acid phenylalanine.
A medical food is intended for use under the supervision of a physician. It doesn’t include products such as meal replacements or diet shakes, or products for the management of diseases, such as diabetes, that can be managed through modification of the normal diet alone.
Medical foods do not undergo premarket approval by the FDA. Still, medical food companies must comply with other requirements, such as current good manufacturing practices and registration of food facilities. Medical foods do not have to include a Nutrition Facts label on their labels; however, any statements on their label or in other labeling must be truthful and not misleading.
The FDA does not approve infant formulas before they can be marketed. But manufacturers of infant formula are subject to the FDA’s regulatory oversight.
Manufacturers must ensure that their infant formula complies with federal nutrient requirements and other regulations. Manufacturers must register with the FDA and provide the agency with an infant formula submission before marketing a new formula.
The FDA conducts yearly inspections of all facilities that manufacture infant formula and collects and analyzes product samples. The FDA also inspects new facilities. If the FDA determines that an adulterated or misbranded infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.
The FDA is not authorized to approve dietary supplements for safety and effectiveness. In fact, many dietary supplements can be marketed without even notifying the FDA.
But companies are required to submit a premarket safety notification to the FDA at least 75 days before marketing dietary supplements containing certain “new dietary ingredients” (that were not marketed in the U.S. before Oct. 15, 1994).
Dietary supplement companies must ensure their products are safe before marketing and comply with other labeling and quality requirements, such as good manufacturing practices.
The FDA inspects facilities for compliance and monitors adverse event reports. When public health concerns arise about the safety of a dietary supplement or an ingredient, the FDA has the authority to take action to protect the public.
The FDA does not approve individual food labels before food products can be marketed. But FDA regulations require specific labeling elements, including nutrition information, to appear on most foods, including dietary supplements. Also, any statements on food products must be truthful and not misleading – and must comply with any regulatory requirements for the type of statement, as applicable.
Manufacturers must provide the serving size of the food and specified information about the nutrient content of each serving on the “Nutrition Facts” label (or on the “Supplement Facts” label for dietary supplements).
Structure-function claims describe the role of a food or food component (such as a nutrient) that is intended to affect the structure or function of the human body. One example is “calcium builds strong bones.”
Dietary supplement companies that make structure-function claims on labels or in other labeling must submit a notification to the FDA. Structure-function claims on dietary supplements carry a disclaimer stating that the claim has not been evaluated by the FDA, and that the product is not intended to diagnose, treat, cure, or prevent any disease.
The FDA does not require conventional food manufacturers to notify the FDA about their structure-function claims or to carry a disclaimer. By law, all such claims must be truthful and not misleading.
The FDA’s logo is for official government use only. The FDA’s logo should not be used to misrepresent the agency or to suggest that the FDA endorses any private organization, product, or service.
These are just some of the many ways the FDA is responsible for protecting the public health.
Source: US Federal Emergency Management Agency
Headline: Returning Home after the LA County Wildfires
Returning Home after the LA County Wildfires
LOS ANGELES – As more Eaton Canyon and Pacific Palisades neighborhoods impacted by Los Angeles County wildfires open to residents, city and county officials caution that these areas are still dangerous, due to considerable risks remaining from waste, unstable burned buildings, and utility crews using heavy equipment.Everyone is eager to go home, clean up the burn site and start rebuilding. You may be worried about what you will find when you get back — but don’t rush in. If you find your home has damage, be careful. Improper handling and disposal of ash and materials may impact your health, as well as your neighbors. Recovery calls for caution. Areas Damaged by Wildfires are Reopening, but Risk Remains Almost all areas are now open, but some limited access may persist due to downed power lines, landslides, debris, unstable roads, or other utility work. Los Angeles County officials will communicate when re-entry conditions are permissible through public media. To check on your area, visit the county’s disaster website at Eaton Fire – LA County Recovers / Palisades Fire – LA County Recovers.The more a neighborhood is damaged by wildfire, the more complex and lengthier it will be to make the area safe. Below are some factors that help determine when a disaster area can be considered safe:Fire debris and ash in roadways. Crews have been working to clear roadways to ensure survivors can safely travel back to their homes or businesses. Debris removal has begun in Phase 1 of two phases. For more information on the process, visit Debris Removal – LA County Recovers Household materials removal. Exposure to certain common household materials impacted by fire may be a risk to human health, animals, and the environment. During Phase 1, the U.S. Environmental Protection Agency (EPA) has been surveying, removing, and disposing of household materials that may require special handling from properties affected by the wildfires. Items being removed include materials such as paints, solvents, oils, vehicle, and household batteries, and pesticides. For more information visit: 2025 California Wildfires | US EPA.In Phase 2, the U.S. Army Corps of Engineers was tasked to support FEMA and the Consolidated Debris Removal Program. Corps of Engineers contractors will remove fire-damaged debris from private property. Residents must opt-in to the Debris Removal Program and obtain a Right-of-Entry (ROE) form for the Corps of Engineers to access charred properties. Property owners are not required to use these services. Residents who do not “opt-in” to the Debris Removal Program are responsible for all associated debris removal costs. In addition, for the safety of the community, property owners who choose to do their own cleanup must still follow local, state, and federal requirements.Use Caution When Returning HomeBring personal protective equipment for working in and around your home: gloves, eye protection, face masks or respirators, and boots with a steel toe and insole.Look for damaged power lines, foundation cracks and other exterior damage. Your home may be too dangerous to enter before an inspector checks it out.Don’t turn on your electrical breaker if it looks damaged. Keep the main electrical power and water systems off until you or a professional can ensure they are safe.Check your gas meter and gas lines for damage. If you smell natural gas or propane, hear a hissing noise, or notice visible damage, leave immediately and contact the fire department.If your home and electrical system appear undamaged, but the power is off, turn off all your appliances before you turn the power back on at the main breaker.Take it one step at a time. Focus on the most important clean-up tasks first. Don’t try to move large or unstable material by yourself. Ask for help and help others.Rebuild with the Future in MindYou can rebuild or repair your home in ways that reduce your risk from wildfires. Email FEMA Mitigation to request a free individualized plan: FEMA-R9-MIT@fema.dhs.gov. When choosing a contractor, please note: Contractors should be licensed and bonded and have disability and workers’ compensation insurance. If they don’t, you may be liable for accidents on your property.Make sure contractors obtain the necessary permits to do the job. Consult your local government and/or LA County to verify that they do.
barbara.murien…
Wed, 02/05/2025 – 17:44
Source: US Federal Emergency Management Agency
Headline: Don’t Wait! Friday is the last day to apply for FEMA assistance in Mercer County, W.Va.
Don’t Wait! Friday is the last day to apply for FEMA assistance in Mercer County, W.Va.
CHARLESTON, W.Va. – Friday is the last day for Mercer County residents to apply for FEMA Assistance if they had damages from the Sept. 25-28, 2024, remnants of Tropical Storm Helene. THE DEADLINE TO APPLY IS FRIDAY, FEB. 7, 2025.FEMA assistance for individuals and families affected by the flooding can cover home repairs, personal property losses and other disaster-related needs not covered by insurance.Survivors can visit the Disaster Recovery Center (DRC) to apply and talk face-to-face with FEMA staff. The Mercer County recovery center location and hours are as follows: Princeton Disaster Recovery CenterLifeline Princeton Church of God250 Oakvale Road Princeton, WV 24740Hours of operation:Monday to Friday: 9 a.m. to 5 p.m.Closed Saturday and SundayDRCs are accessible to all, including survivors with mobility issues, impaired vision, and those who are who are Deaf or Hard of Hearing.An easy way to apply for FEMA assistance is by phone at 800-621-3362. The toll-free telephone line operates from 7 a.m. to 11 p.m., seven days a week. If you use a relay service, such as video relay service (VRS), captioned telephone service or others, give FEMA your number for that service. Residents can also apply or online at DisasterAssistance.gov or download the FEMA app to their smartphone or tablet.Friday, Feb. 7, 2025, is also the final deadline for homeowners, renters and business owners to apply for a U.S. Small Business Administration physical disaster loan. Applicants can apply online at sba.gov/disaster, call SBA’s Customer Service Center at (800) 659-2955, or email disastercustomerservice@sba.gov for more information on SBA disaster assistance. For people who are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay service.For more information on West Virginia’s disaster recovery, visit emd.wv.gov, West Virginia Emergency Management Division Facebook page, www.fema.gov/disaster/4851 and www.facebook.com/FEMA.###FEMA’s mission is helping people before, during and after disasters. FEMA Region 3’s jurisdiction includes Delaware, the District of Columbia, Maryland, Pennsylvania, Virginia and West Virginia.Follow us on X at x.com/FEMAregion3 and on LinkedIn at linkedin.com/company/femaregion3.Disaster recovery assistance is available without regard to race, color, religion, nationality, sex, age, disability, English proficiency or economic status. If you or someone you know has been discriminated against, call FEMA toll-free at 833-285-7448. If you use a relay service, such as video relay service (VRS), captioned telephone service or others, give FEMA your number for that service. Multilingual operators are available (press 2 for Spanish and 3 for other languages).
erika.osullivan
Wed, 02/05/2025 – 15:31
Source: US Food and Drug Administration
Today, the U.S. Food and Drug Administration is alerting patients of a safety concern regarding diabetes devices, such as continuous glucose monitors (CGMs), insulin pumps and automated insulin dosing systems, that rely on a smartphone to deliver critical safety alerts. Users of these smartphone-compatible diabetes devices can configure alert settings, such as which alerts to receive, how often and how the alerts are delivered (e.g. audible, vibration, text only) through the app on their phone.
The FDA has received medical device reports in which users report these alerts are not being delivered or not being heard, in cases where the users thought they had configured the alerts to be delivered. In some cases, missing these alerts may have contributed to serious harm, including severe hypoglycemia (low blood sugar), severe hyperglycemia (high blood sugar), diabetic ketoacidosis (when the body does not have enough insulin to use blood sugar for energy) and death.
“Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them. However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected,” said Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA’s Center for Devices and Radiological Health. “Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected.”
The FDA has identified, among others, the following hardware and software changes, updates and configurations that may lead to critical alerts not being received as expected:
The FDA’s safety communication provides recommendations, such as the following, for users of these devices:
The FDA is working with diabetes-related medical device manufacturers to ensure that smartphone alert configurations of their devices are carefully evaluated prior to use by patients. The agency is also working with manufacturers to ensure that settings in smartphones and mobile medical apps that may impact safety alerts are continuously tested and any updates to recommended configurations are communicated quickly and clearly to users.
###
Boilerplate
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
Source: US Federal Emergency Management Agency
Headline: Two Days Left for Georgians to Apply for Federal Disaster Assistance
Two Days Left for Georgians to Apply for Federal Disaster Assistance
The deadline is quickly approaching for Georgia survivors of Tropical Storm Debby (Aug. 4—20. 2024) and Hurricane Helene (Sept. 24—Oct. 30, 2024) in the counties designated for Individual Assistance to apply federal assistance.The application period to apply for federal disaster assistance ends in two days, on Friday, Feb. 7, 2025.Counties approved for assistance for Hurricane Helene are: Appling, Atkinson, Bacon, Ben Hill, Berrien, Brantley, Brooks, Bryan, Bulloch, Burke, Butts, Camden, Candler, Charlton, Chatham, Clinch, Coffee, Colquitt, Columbia, Cook, Dodge, Echols, Effingham, Elbert, Emanuel, Evans, Fulton, Glascock, Glynn, Hancock, Irwin, Jeff Davis, Jefferson, Jenkins, Johnson, Lanier, Laurens, Liberty, Lincoln, Long, Lowndes, McDuffie, McIntosh, Montgomery, Newton, Pierce, Rabun, Richmond, Screven, Stephens, Taliaferro, Tattnall, Telfair, Thomas, Tift, Toombs, Treutlen, Ware, Warren, Washington, Wayne, Wheeler and Wilkes.Counties approved for assistance for Tropical Storm Debby are: Bryan, Bulloch, Chatham, Effingham, Evans, Liberty, Long and Screven.There are four ways to apply for assistance:Online at DisasterAssistance.gov.The FEMA App for mobile devicesCall toll-free 800-621-3362. Survivors can also contact the Georgia Call Center Monday through Saturday at 678-547-2861 for assistance with their application.FEMA Disaster Recovery Centers. For locations and hours, go online to fema.gov/drcFEMA provides help to all disaster survivors, regardless of race, color, national origin, sex, sexual orientation, religion, age, disability, English proficiency or economic status. Our top priority is ensuring that disaster assistance is reaching people in need.For the latest information about Georgia’s recovery, visit fema.gov/helene/georgia and fema.gov/disaster/4821. Follow FEMA on X at x.com/femaregion4 or follow FEMA on social media at: FEMA Blog on fema.gov, @FEMA or @FEMAEspanol on X, FEMA or FEMA Espanol on Facebook, @FEMA on Instagram, and via FEMA YouTube channel. Also, follow Acting Administrator Cameron Hamilton on X @FEMA_Cam.
jakia.randolph
Wed, 02/05/2025 – 13:37
Source: US Food and Drug Administration
This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
On November 26, 2024, Jiangsu Jumao X-Care Medical Equipment Co., Ltd. sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD is recalling certain devices due to incidents of device melting and fire during the use of oxygen concentrators. The cause of the fires and melting remains under investigation.
The use of affected product may cause serious adverse health consequences, including exposure to excess heat and fire that could lead to burns and possibly death.
There have been no reported injuries. There have been no reports of death.
The TRUAIRE-5 O2 CONCENTRATOR (Model O2C5L) is intended to provide supplemental oxygen to patients with respiratory disorders by separating nitrogen from room air by way of a molecular sieve. It is not intended to sustain or support life.
Customers in the U.S. with questions about this recall should contact Compass Health Brands Corp at 1-800-376-7263 x444.
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Source: GlobeNewswire (MIL-OSI)
Nokia Corporation
Stock Exchange Release
5 February 2025 at 22:30 EET
Nokia Corporation: Repurchase of own shares on 05.02.2025
Espoo, Finland – On 5 February 2025 Nokia Corporation (LEI: 549300A0JPRWG1KI7U06) has acquired its own shares (ISIN FI0009000681) as follows:
| Trading venue (MIC Code) | Number of shares | Weighted average price / share, EUR* |
| XHEL | 1,400,000 | 4.53 |
| CEUX | – | – |
| BATE | – | – |
| AQEU | – | – |
| TQEX | – | – |
| Total | 1,400,000 | 4.53 |
* Rounded to two decimals
On 22 November 2024, Nokia announced that its Board of Directors is initiating a share buyback program to offset the dilutive effect of new Nokia shares issued to the shareholders of Infinera Corporation and certain Infinera Corporation share-based incentives. The repurchases in compliance with the Market Abuse Regulation (EU) 596/2014 (MAR), the Commission Delegated Regulation (EU) 2016/1052 and under the authorization granted by Nokia’s Annual General Meeting on 3 April 2024 started on 25 November 2024 and end by 31 December 2025 and target to repurchase 150 million shares for a maximum aggregate purchase price of EUR 900 million.
Total cost of transactions executed on 5 February 2025 was EUR 6,336,400. After the disclosed transactions, Nokia Corporation holds 239,524,606 treasury shares.
Details of transactions are included as an appendix to this announcement.
On behalf of Nokia Corporation
BofA Securities Europe SA
About Nokia
At Nokia, we create technology that helps the world act together.
As a B2B technology innovation leader, we are pioneering networks that sense, think and act by leveraging our work across mobile, fixed and cloud networks. In addition, we create value with intellectual property and long-term research, led by the award-winning Nokia Bell Labs.
With truly open architectures that seamlessly integrate into any ecosystem, our high-performance networks create new opportunities for monetization and scale. Service providers, enterprises and partners worldwide trust Nokia to deliver secure, reliable and sustainable networks today – and work with us to create the digital services and applications of the future.
Inquiries:
Nokia Communications
Phone: +358 10 448 4900
Email: press.services@nokia.com
Maria Vaismaa, Global Head of External Communications
Nokia Investor Relations
Phone: +358 931 580 507
Email: investor.relations@nokia.com
Attachment
Source: European Parliament
The EU strongly supports the fundamental aspiration of the people of Iran for a future where their universal human rights and fundamental freedoms are respected, protected and fulfilled.
The EU continuously engages and supports civil society both inside and outside Iran through the Commission, the High Representative/Vice-President, in cooperation with the European Parliament.
In the December 2022 Council conclusions[1], the EU reconfirmed its resolute commitment to human rights in its policy towards Iran. Fundamental rights such as freedom of expression, both online and offline, freedom of assembly and freedom of association must be respected in all circumstances, and this can only be ensured by the existence of a strong and free civil society.
The EU has reacted promptly, both publicly and privately, to human rights violations in Iran, including by strongly supporting United Nations accountability mechanisms.
The EU’s humanitarian assistance has been instrumental in supporting the lifesaving needs of displaced Afghans in Iran, the world’s largest host country for refugees.
In 2024, the EU allocated EUR 12.45 million[2] for humanitarian programmes to respond to the needs of the most vulnerable, notably women and children, focusing on food security, health and education, among other areas.
The humanitarian assistance funded by the EU is delivered in partnership with United Nation’s agencies, international organisations and non-governmental organisations.
Source: European Central Bank
Washington, D.C., 5 February 2025
It is a pleasure to be here at the Peterson Institute for International Economics (PIIE): your impressive research on a wide range of topics is extremely valuable for policymakers.[1]
At last week’s monetary policy meeting, the ECB’s Governing Council decided to lower the deposit facility rate – the rate through which we steer the monetary policy stance – by 25 basis points from 3.0 per cent to 2.75 per cent. In cumulative terms, the deposit facility rate has declined by 125 basis points since last June. The decision reflected our updated assessment of the inflation outlook, the dynamics of underlying inflation and the strength of monetary policy transmission.
In what follows, I will explain in more detail the basis for this decision. I will review inflation developments, economic developments, our risk assessment, and financial and monetary conditions. Finally, I explain why pursuing a middle path for monetary policy is best suited to the current environment.
The disinflation process remains well on track. Inflation has continued to develop broadly in line with the staff projections and is set to return to our two per cent medium-term target in the course of this year. Most measures of underlying inflation suggest that inflation will settle at around our target on a sustained basis. The Persistent and Common Component of Inflation (PCCI), which has the best predictive power among underlying inflation indicators for future headline inflation, continued to hover around two per cent in the December data, indicating that headline inflation is set to stabilise around our target.
Domestic inflation, at 4.2 per cent, stayed well above all the other indicators in December mostly because wages and prices in certain sectors are still adjusting to the past inflation surge with a substantial delay. However, the PCCI for services, which should act as an underlying attractor for services inflation and domestic inflation, fell to 2.3 per cent.
The anticipation of a downward shift in services inflation in the coming months also relates to the expected deceleration in wage growth in the course of 2025. Wages have been adjusting to the past inflation surges with a substantial delay, but the ECB wage tracker and the latest surveys point to a significant moderation in wage pressures this year. According to the latest results of the Survey on the Access to Finance of Enterprises (SAFE), firms expect wages to grow by 3.3 per cent on average over the next twelve months, down from 4.5 per cent this time last year. Similarly, the latest Corporate Telephone Survey indicates that wage growth should decelerate from 4.6 per cent in 2024 to 3.3 per cent in 2025 and 2.9 per cent in 2026. This assessment is shared broadly among forecasters. Consensus Economics, for example, foresees a decline in wage growth by about one percentage point between 2024 and 2025.
Most measures of longer-term inflation expectations continue to stand at around two per cent, despite an uptick at shorter horizons that may reflect the recent rise in energy prices. While the inflation expectations of firms have stabilised at three per cent across horizons, according to the SAFE, larger firms that are aware of the ECB’s inflation target show convergence towards two per cent. Consumer inflation expectations have edged up recently, especially for the near term, which can at least be partly explained by their higher sensitivity to the recent uptick in realised inflation. Inflation expectations of professionals – as captured by the latest vintages of the Survey of Professional Forecasters and Survey of Monetary Analysts – as well as market-based measures of inflation compensation have ticked up for the near term but, over longer horizons, remain stable at levels consistent with our medium-term target of two per cent.
On a fourth-quarter-to-fourth-quarter basis, the 2024 growth rate came in at 0.9 per cent, constituting a material improvement in momentum relative to the 2023 growth rate of 0.1 per cent. While 2024 saw a modest recovery in consumption, investment remained weak and exporters continued to suffer competitiveness challenges. In terms of the quarterly profile, growth stagnated in the final quarter following a comparatively robust third quarter.
The incoming survey indicators suggest that the euro area economy is set to remain subdued in the near term. While unemployment remained low at 6.3 per cent in December, there has been some softening in labour demand, as reflected in lower vacancies and lower employment growth.
At the same time, our baseline assessment is that the conditions for a recovery remain in place. Higher incomes, lower interest rates and stronger household balance sheets should allow a faster pick-up in consumption. More affordable credit should also boost housing and business investment over time. Exports should also support the recovery as global demand rises, although this is highly conditional on developments in international trade policies.
Global and euro area bond yields have increased significantly since our last meeting. Amongst other factors, the spillover impact of the rise in US and global longer-term rates has contributed to the steepening of the euro area yield curve.
Our past interest rate cuts are gradually making it less expensive for firms and households to borrow. The cost of borrowing for firms has declined by 92 basis points and mortgage rates have declined by 62 basis points since their peaks in autumn 2023. However, the interest rates on existing corporate and household loan books remain high, especially in real terms, with pre-2022 debt still re-pricing at higher rates as fixation periods expire.
In overall terms, financing conditions remain tight. While credit is expanding, lending to firms and households remains subdued relative to historical norms. Growth in bank lending to firms rose to 1.5 per cent in December. In part, the pick-up in December reflects firms substituting market-based long-term financing for bank-based borrowing amidst tightening market conditions and increasing upcoming redemptions of long-term corporate bonds. Overall external debt financing of firms increased by 1.9 per cent in December, but remained well below the historical average of 4.9 per cent.[2] Loans to households continued to rise gradually, driven by mortgages, but remained muted overall, with an annual growth rate of 1.1 per cent in December, notably below the long-term average of 4.2 per cent.
According to the latest bank lending survey, the demand for loans by firms increased slightly in the fourth quarter. At the same time, credit standards for loans to firms have tightened again, after having broadly stabilised over the previous four quarters. The renewed tightening of credit standards for firms was driven by the fact that banks see higher risks to the economic outlook and have lower tolerance for taking on credit risk. This finding is consistent with the results from the SAFE, in which firms reported a small decline in the availability of bank loans and more demanding non-rate lending conditions. In terms of households, the demand for mortgages increased strongly, mostly on the back of more attractive interest rates and better prospects for the property market. Credit standards for housing loans remained unchanged overall.
Risks to economic growth remain tilted to the downside. In addition to trade policy uncertainty, lower confidence could prevent consumption and investment from recovering as fast as expected. This could be amplified by geopolitical risks, such as Russia’s unjustified war against Ukraine and the tragic conflict in the Middle East, which could disrupt energy supplies and further weigh on global trade. Growth could also be lower if the lagged effects of monetary policy tightening last longer than expected. In the other direction, growth could be higher if easier financing conditions and falling inflation allow domestic consumption and investment to rebound faster.
We take a two-sided approach to assessing inflation risk. Inflation could turn out higher if wages or profits increase by more than expected. Upside risks to inflation also stem from the heightened geopolitical tensions, which could push energy prices and freight costs higher in the near term and disrupt global trade. Moreover, extreme weather events, and the unfolding climate crisis more broadly, could drive up food prices by more than expected. By contrast, inflation may surprise on the downside if low confidence and concerns about geopolitical events prevent consumption and investment from recovering as fast as expected, if monetary policy dampens demand by more than expected, or if the economic environment in the rest of the world worsens unexpectedly. Greater friction in global trade would make the euro area inflation outlook more uncertain.
Taken together, the incoming data since our previous meeting meant that it was clear that we should take a further step in monetary easing by lowering the deposit facility rate to 2.75 per cent. By excessively dampening demand, the alternative of holding the deposit facility rate at the level of 3.0 per cent would not have been consistent with the set of rate paths that would best ensure that inflation stabilises sustainably at our two per cent medium-term target. At the same time, the new level for the deposit facility rate at 2.75 per cent preserves considerable optionality in responding to shocks. In particular, the rate path can adjust as appropriate in the event of material upside or downside shocks to the inflation outlook and/or to economic momentum.
While our baseline is that inflation should decline from 2.5 per cent in January to around our target in the coming months, it is still important to take into account that this deceleration might take longer than expected and that new upside risks to inflation could emerge, including due to external developments. These considerations explain why we have taken a step-by-step approach to rate cutting since last June.
At the same time, an excessive abundance of caution in monetary easing could threaten the recovery in domestic demand that is needed to support the pricing environment compatible with our medium-term two per cent target. Under this too-cautious path, a below-target inflation dynamic could take hold, which would then require a more sizeable policy response to ensure inflation returns to our symmetric two per cent medium-term target.
Balancing these considerations suggest a middle path is appropriate, which neither over-weighs upside risk nor over-weighs downside risk. That is, a robust monetary policy approach should balance the risks of moving too slowly against the risks of moving too quickly. Accordingly, it is prudent to maintain agility in adjusting the stance as appropriate on a data-dependent and meeting-by-meeting basis and to not pre-commit to any particular rate path.
In closing, let me comment on two much-discussed concepts: restrictiveness and neutrality.
When inflation is materially above target and requires a monetary response to ensure that it returns to target in a timely manner and that inflation expectations remain anchored, the monetary stance must be clearly restrictive. As inflation returns close to target, policymakers need to shift their focus to adjusting monetary policy in line with the incoming economic and financial data and the evolving risk assessment to deliver the two per cent target over the medium term. In other words, policymakers should deliver the monetary stance that is appropriate to the situation.
In exiting a restrictive phase, much energy could be diverted towards creating a summary “restrictiveness” index. Any such index would have to incorporate at least nine factors: (i) the still-important rolling off of super-cheap debt that was taken out in the “low for long” era that is now being re-financed at higher rates; (ii) in the other direction, the transmission of the easing since the peak of the hiking cycle; (iii) the impact of the anticipation of future rate cuts on current financing conditions; (iv) the evolving contribution of quasi-exogenous influences on financing conditions (such as global upward pressure on term premia); (v) the dynamics of bond and equity risk premia; (vi) the evolution of credit standards in bank lending; (vii) the different timelines for market-based and bank-based transmission; (viii) the responsiveness of consumption and investment to shifting monetary conditions; and (ix) the responsiveness of price setting to shifting monetary conditions.
All of these factors enter our calibration of monetary policy (our assessment of the strength of monetary policy transmission has been highlighted as central to our reaction function) and cannot be summarised by a single indicator such as comparing the prevailing policy rate to a highly-uncertain estimate of the so-called neutral rate.[3]
In terms of policy making, uncertainty about the level of the neutral rate and, more generally, about the strength of monetary transmission inescapably sits alongside uncertainty about the inflation outlook and uncertainty about the economic outlook.
This is why our 2021 monetary policy strategy statement highlights that our decisions are based on an integrated assessment of all relevant factors. Over the last two years, we have emphasised in particular the importance of underlying inflation and the strength of monetary transmission as particularly relevant in complementing our analysis of the inflation outlook. More generally, it is essential that all relevant risks are incorporated in monetary policy decisions.
Source: European Parliament
The next meeting of the Delegation to the EU-Mexico Joint Parliamentary Committee (D-MX) is scheduled for:
Wednesday, 12 February 2025, 17.00-19.00
Room: DE MADARIAGA S5 (Strasbourg)
It will include an Exchange of views on the modernization of the EU-Mexico Global Agreement and perspectives of enhanced political and economic cooperation between the EU and Mexico.
Source: European Parliament
As part of its comprehensive policy approach towards Iran[1], the EU has responded strongly on human rights violations and abuses by Iranian authorities, including against the country’s ethnic and religious minorities.
The EU is using all diplomatic venues, including multilateral fora, to repeatedly and firmly call on the Iranian authorities to ensure the full enjoyment of human rights and fundamental freedoms for all Iranians, as well as persons belonging to ethnic, religious and linguistic minorities, including the Bahá’ís.
Furthermore, the EU has so far listed a total of 269 individuals and entities under the sanctions regime adopted in response to serious human rights violations in Iran[2].
The EU will continue to use all tools at its disposal and will continue to be a strong supporter of the United Nations accountability mechanisms investigating the alleged human rights violations in Iran, including on the country’s ethnic and religious minorities.
Source: European Parliament
Swift and effective implementation of the Pact on Migration and Asylum[1] is a top priority for the Commission.
The obligation for Member States to establish national implementation plans stems from Article 84 of the Asylum and Migration Management Regulation[2], which specifies that ‘by 12 December 2024, each Member State shall, with the support of the Commission and relevant EU bodies, offices and agencies, establish a national implementation plan setting out the actions and the timeline for their implementation’.
In the common implementation plan presented on 12 June 2024, the Commission invited Member States to share their draft plans by October 2024 to support this overall process. Almost all Member States submitted their draft national implementation plans by that date.
The Commission is engaging in dialogue with all Member States to support the development and implementation of their national implementation plans.
The Commission will inform the Parliament and the Council about the state of play of the common implementation plan and the national implementation plans on a six-monthly basis, in line with its obligations under the asylum and Migration Management Regulation.
Source: European Parliament
For all Sustainable Fisheries Partnership Agreements (SFPAs), the Commission is required to conduct an ex post evaluation when a protocol expires, as well as an ex ante evaluation setting out recommendations for a new SFPA implementing protocol.
As part of this process, the Commission consults all stakeholders, including industry, in particular through the Long Distance Advisory Council. All evaluations are sent to the European Parliament and published on the website of the Publications Office of the European Union.
The negotiating guidelines proposed by the Commission for adoption by the Council are based on these recommendations. They take the requirements of the European fleet fully into account, while ensuring compliance with the provisions of the United Nations Convention on the Law of the Sea, particularly when it comes to defining surplus.
Negotiations with the partner country determine the outcome of any fisheries agreement that is ultimately signed. The fishing opportunities that are negotiated are then allocated to the Member States by means of a Council Regulation.
With regard to the fisheries agreement with Morocco, the last implementing protocol expired in July 2023 and the corresponding evaluation has been published[1].
The Commission has taken note of the judgments handed down by the Court of Justice of the European Union[2] on the appeals brought against the judgment of the General Court of 29 September 2021, and is currently analysing them in detail.
Source: European Parliament
1. The Commission is continuously monitoring the situation in Lebanon and the Middle East, including within the framework of the EU Migration Preparedness and Crisis Blueprint[1], ensuring common situational awareness and information sharing with the Member States, the European External Action Service and EU Agencies to monitor and anticipate migration movements, and to ensure preparedness and operational support as needed.
2. The Commission stands ready to further support Member States, including Greece and Cyprus with whom there are regular contacts, in managing upcoming migration management challenges, by continuing its financial and operational support, with the support of EU Agencies[2]. The Commission remains committed to the implementation of the action plan for the Eastern Mediterranean[3]. In the context of the ongoing implementation process for the Pact on Migration and Asylum[4], the Commission supports Member States in addressing shortcomings and completing reforms to ensure the establishment of a well-prepared migration management system by 2026, including measures to ensure preparedness, contingency planning and crisis response.
3. To support Member States in addressing needs with regards to migration management and border management, the Commission provides support through the Home Affairs Funds[5]. The EU Civil Protection Mechanism (UCPM)[6] allows Member States and UCPM participating states to request assistance, including from the Commission’s emergency stockpiles (rescEU)[7], to provide relief materials to countries in need of extra resources. The Mechanism already delivered shelter materials to Cyprus in October 2023, in preparation for a potential arrival of a large number of people from the Middle East.
Source: European Parliament
Between 24 and 28 February 2025, IMCO Members are going to visit Washington DC. The main aim of this visit is to strengthen the transatlantic cooperation on key policy IMCO areas while obtaining feedback from U.S. stakeholders on the implementation and impact of major EU legislation, including the Digital Services Act (DSA), Digital Markets Act (DMA), EU AI Act, Cyber Resilience Act (CRA), Data Act, and Political Advertising Regulation.
The Members of the European Parliament traveling to Washington for the parliamentary visit are Anna Cavazzini (IMCO Chair, Greens/EFA), Andreas Schwab (EPP), Pablo Arias Echeverría (EPP), Christel Schaldemose (S&D), Klára Dostálová (PfE), Piotr Müller (ECR), and Sandro Gozi (Renew).
Source: European Parliament
The Commission proposal for the 2025 fishing opportunities under the legislative framework of the Western Mediterranean management plan[1] (MAP) is based on the best available scientific advice provided by the Scientific, Technical and Economic Committee for Fisheries[2] (STECF).
The advice showed that several of the stocks concerned by the MAP are outside of safe biological limits and important catch reductions are needed for the stocks to recover.
The MAP’s aim is to secure a sustainable and profitable future for the sector relying on healthy fish stocks. While the fishing opportunities adopted by the Council have gradually reduced the trawling effort since 2020, numerous flexibilities alleviated the total reduction, such as the recovered fishing days granted by the compensation mechanism.
European financial assistance is available to those fishers who opt in. For 2025, the Council adopted the fishing effort reductions proposed by Commission, together with an expanded compensation mechanism based on conservation measures. The Commission will continue working with the Member States and the fishing sector for the implementation of the MAP.
The socioeconomic specificities of the Western Mediterranean fisheries were considered during the negotiations of the MAP, and the co-legislators agreed to postpone the binding rule for Maximum Sustainable Yield to 2025[3].
The Commission has worked based on STECF socioeconomic analyses that conclude how ambitious management measures will rapidly pay off with more healthy stocks and increased sector profitability.
The Commission worked with all stakeholders to implement gradually the MAP and has continuously recommended a broad range of measures[4] to help with its implementation .
Source: European Parliament
The EU has expressed its concerns about reports regarding the repatriation to the Democratic People’s Republic of Korea (DPRK) of North Koreans detained in China and has reiterated the importance of upholding the principle of non-refoulement.
The EU has repeatedly raised this issue with China through diplomatic channels, asking China to refrain from returning North Korean refugees to the DPRK. The EU will continue to urge China to fully respect the principle of non-refoulement.
The EU has noted with concern that foreign citizens remain arbitrarily detained in the DPRK, often following trials that do not conform with international fair trial guarantees, with no information available regarding their health or the conditions of their detention.
The EU will continue to insist that the DPRK must respect its international human rights obligations, including with regard to the cases referred to in the written question.
The EU has called on the DPRK to provide citizens of other countries detained in the DPRK with protections including access to consular assistance and to release persons that have been arbitrarily detained or sentenced after an unfair trial.
The EU in principle does not enumerate individual consular cases in the annual Human Rights Council resolution on human rights in the DPRK.
The cases relating to Myanmar concerned the highest representatives of the democratically elected government, detained after an unjustified, illegal and unconstitutional military coup.
Source: European Parliament
The EU and the Kingdom of Saudi Arabia (KSA) maintain a growing partnership based on regional stability, sustainable development and economic transformation, aligned with the 2022 EU Gulf Strategy[1] and Saudi Vision 2030[2].
The Crown Prince’s participation in the first EU-Gulf Cooperation Council (GCC) Summit in Brussels in October 2023 underscored KSA’s commitment to a stronger, forward-looking partnership with the EU in key areas, notably trade, investment, energy, connectivity, and green and digital transitions.
Under the 2021 EU-KSA Cooperation Arrangement[3], the two sides hold annual political dialogues; the last one took place in Brussels in July 2023, as well as annual Senior Officials Meetings on global issues, the last one took place in Riyadh in September 2023.
The KSA also hosts the first in the region EU-GCC Chamber of Commerce. In addition, the EU and KSA hold annual formal Human Rights Dialogues, addressing all rights issues and cooperation in multilateral fora, the most recent one in Riyadh in December 2024.
The EU Special Representative for the Gulf also contributes to strengthening the EU-KSA partnership, particularly on regional security, as reflected at the April 2024 EU-GCC High-Level Forum on regional security, attended by the KSA Minister of Foreign Affairs.
The KSA is a key EU partner for regional security and stability, notably in the framework of the joint EU-Norway-KSA Global Alliance for implementation of the two-state solution, with participation of more than 90 countries. The KSA Minister of Foreign Affairs has also joined relevant Foreign Affairs Council discussions.
The EU and KSA are currently finalising the negotiations on a memorandum of understanding on Energy Transitions and Clean Technology Cooperation, focusing on low emissions, renewables, hydrogen, and energy efficiency.
Source: European Parliament
In 2024, the Commission allocated a total of EUR 4.4 million in humanitarian assistance to Cuba. The Commission has closely followed the impacts of recent hurricanes and earthquakes, compounding an already dire situation in the country. A humanitarian expert was deployed to assess the needs after the disasters stroke.
The Commission supported the emergency response with further EUR 3.9 million. In addition, it deployed a humanitarian airbridge to transport more than 100 tons of humanitarian supplies from the United Nations, EU, and Spanish stocks in five flights, providing relief to populations affected by hurricane Oscar.
Furthermore, it allocated EUR 500 000 in humanitarian aid to respond to urgent health needs due to medicine shortages across the country. The EU stands ready to provide additional humanitarian aid based on assessments of new needs.
In a longer-term perspective, the EU will continue to provide support under the Multiannual Indicative Programme 2021-2027[1] and through the Global Gateway[2] to strengthen development and resilience. This includes programmes in crucial sectors such as water and sanitation, and energy.
The EU has a longstanding cooperation in both sectors and through the Global Gateway there is potential for European investments on renewable energy infrastructure.
Source: European Parliament
The fall of Assad’s regime is a historic moment for the extraordinarily resilient Syrian people, who have suffered in their pursuit of dignity, freedom, and justice.
The EU’s principled and firm approach proved to be right. Now an inclusive, Syrian-led and Syrian-owned political solution, in the spirit of the United Nations (UN) Security Council Resolution 2254[1], is more urgent than ever.
In the Statement of 9 December 2024[2], the EU ‘urge[d] all actors to avoid any further violence… and urge[d] the protection of members of all minorities, including of Christian and other non-majority confessions.’
On 14 December 2024, in Jordan, the High Representative/Vice-President participated in an international meeting on Syria where Arab countries and other partners agreed on principles of engagement with the new authorities.
These included an inclusive political process with UN support, a government representative of all components of society, the build-up of institutions, the fight against Da’esh, accountability for crimes, and respect by all external actors of Syria’s sovereignty and territorial integrity.
In line with these principles, the EU considers fundamental both the protection of members of all — including ethnic and religious — minorities and their effective inclusion in the political transition.
The EU and its partners will continue to fight terrorism and remain committed to supporting the global coalition against Da’esh and other initiatives to counter violent extremism and radicalism. The EU continues to give help and particular attention to the issue of families of foreign terrorist held in camps in Northeast Syria.
Türkiye’s EU accession talks remain stalled due to democratic and legal setbacks, but the EU values Türkiye as a key partner and seeks progress through constructive cooperation.
Source: European Parliament
Respect for human rights and fundamental freedoms, including freedom of expression, constitutes a key element of EU-Algeria relations, as enshrined in the Association Agreement[1] and reinforced in the Partnership Priorities[2].
On this basis, the EU continues to follow developments and raise concerns on human rights issues with its Algerian counterparts, in line with commitments from both sides.
In particular, the EU addresses human rights in the framework of the EU-Algeria Association Agreement, notably in the Political, Security and Human Rights Dialogue Sub-Committee, and through regular contacts with government officials at all levels, as well as with civil society representatives in Algiers and Brussels.
These discussions include the case of the author Boualem Sansal that the EU continues to follow closely in full coordination with the French authorities as stated by the Commission on 27 November 2024 at the European Parliament[3].
Source: European Parliament
The EU monitors the human rights situation in the Kyrgyz Republic very closely. The EU Delegation in Bishkek is in close contact with local civil society, human rights defenders and independent media, and regularly attends trials of journalists, human rights defenders and non-governmental organisations and cases where human rights are suspected of having been violated.
Individual human rights cases and general concerns in relation to human rights are raised during meetings with the Kyrgyz authorities at every level, and most recently at the 14th Human Rights Dialogue held on 21 November 2024 in Bishkek.
Throughout 2024, the High Representative/Vice-President issued statements on developments of concern, including on 2 April 2024 on the adoption of the ‘Foreign Representatives’ law[1].
The case of Temirlan Sultanbekov has been raised by the EU Delegation with the Office of the General Prosecutor, and the authorities have been urged to ensure Mr Sultanbekov’s right to access to justice and to medical care.
In early 2024, the EU Delegation — in response to shrinking space for civil society — published a call for proposals[2] specifically aimed at supporting civil society. Additionally, in 2024, the EU adopted a EUR 5 million programme in support of civil society organisations operating in the area of human rights, gender equality and youth empowerment.
The EU-Kyrgyz Republic Enhanced Partnership and Cooperation Agreement[3], signed in June 2024, provides a strong framework to boost further political dialogue and closer engagement on fundamental freedoms, human rights and democratic values.
Source: European Parliament
The Commission acknowledges the importance of reliable maritime connections on short cross-border routes like Santa Teresa di Gallura-Bonifacio, which support local residents, tourists, and economic activities.
Maritime services between Member States are subject to European Union rules ensuring open and competitive markets[1]. Where market forces alone are insufficient to ensure adequate connectivity, Member States may impose public service obligations (PSOs) or conclude public service contracts (PSCs) in accordance with specific conditions established by EU law[2].
Member States determine operational specifics, in compliance with EU legislation[3]. In case of PSCs with compensation, the state aid rules have to be respected.
The Commission supports Member States by ensuring compliance, facilitating funding through instruments like the European Regional Development Fund or the Recovery and Resilience Facility, and sharing best practices. Italy and France have had opportunity to use these tools to ensure reliable connectivity.
In case of cancellations or delays in departure of more than 90 minutes of waterborne passenger services, the carrier must offer passengers the choice between re-routing to the final destination and reimbursement of the ticket price in accordance with the EU legislation on waterborne passenger rights[4].
Passengers may also be entitled to compensation from the carrier in certain cases. The responsibility for ensuring the correct application and compliance with these rules lies in the first instance with the national enforcement bodies designated in each Member State.
Source: European Parliament
To support the Ukrainian economy following Russia’s unprovoked and unjustified war of aggression against Ukraine, the EU liberalised all imports from Ukraine for which the Association Agreement between the EU and Ukraine[1] limited trade concessions to tariff-rate quotas, by Regulation (EU) 2022/870[2] of 30 May 2022. The measures were prolonged twice[3] and the current iteration will expire on 5 June 2025.
These measures concern agricultural products and processed agricultural products. Under their last iteration from mid-2024, and in order to protect European farmers from growing import levels, automatic safeguards were introduced to limit duty-free imports for the most sensitive sectors, namely sugar, poultry, eggs, maize, honey, oats and groats.
The Commission estimates that the value of Ukrainian agricultural products and processed agricultural products not subject to duties thanks to the measures[4] was around EUR 2.1 billion in 2023 out of the total of Ukraine’s agricultural exports to the EU, which amounted about EUR 12 billion.
In 2024, the value of Ukrainian duty-free exports of agricultural products and processed agricultural products not subject to duties thanks to the measures is estimated at EUR 1.8 billion, a reduction due to the activation of automatic safeguards.
Specifically for eggs and egg products , the value of Ukrainian duty-free exports to the EU in 2023 and 2024 is estimated at EUR 74 million and EUR 38 million, respectively.
Source: European Parliament
The Commission takes note of the concerns raised by the Honourable Member about the potential impact of a future Free Trade Agreement (FTA) with Thailand on the EU tuna processing industry.
In line with the overall EU approach to trade and investment agreements, also in the negotiations with Thailand the Commission aims at reaching a comprehensive deal that can bring growth opportunities for the EU economy and employment as a whole.
In the negotiating rounds held so far, the EU and Thai negotiating teams have focused on advancing on the consolidation of the texts establishing the normative framework for the future trade relations, and have not yet discussed the treatment for individual products.
Detailed and sector specific market access negotiations will start in the coming months, and will include consultations with relevant stakeholders in line with the usual EU practice for FTA negotiations.
As in all FTA processes, economically sensitive sectors are subject to carefully designed specific modalities for market access which aim at preventing any market disturbances.
Furthermore, as the negotiations enter a more advanced stage, a sustainability impact assessment will be carried out in support of the negotiations in order to provide an in-depth analysis of their potential economic, social, human rights, and environmental impacts.
Source: European Parliament
The Commission is aware of the detours that European airlines need to undertake to fly to many Asian destinations. This is a consequence of Russia’s refusal to allow EU airlines to overfly its territory. These detours result in longer and costlier operations to countries like China.
Although in 2016 the Commission proposed to Member States to negotiate an EU aviation agreement with China, Member States chose not to pursue such an agreement. Therefore, air transport between the EU and China is currently governed by bilateral agreements between individual Member States and China.
The Commission stands ready and has offered to engage with Member States in this matter if they so wish.
Source: European Parliament
Committee on the Environment, Public Health and Food Safety
Members responsible: Martin Häusling, Biljana Borzan, Anja Hazekamp
B10‑0061/2025
European Parliament resolution on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize DP910521 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D102174/03 – (2024/3010(RSP))
The European Parliament,
– having regard to the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize DP910521 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D102174/03),
– having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed[1], and in particular Article 7(3) and Article 19(3) thereof,
– having regard to the vote of the Standing Committee on Plants, Animals, Food and Feed referred to in Article 35 of Regulation (EC) No 1829/2003, on 22 November 2024, at which no opinion was delivered, and the vote of the Appeal Committee on 17 December 2024, at which again no opinion was delivered,
– having regard to Article 11 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers[2],
– having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 19 June 2024, and published on 1 August 2024[3],
– having regard to its previous resolutions objecting to the authorisation of genetically modified organisms (‘GMOs’)[4],
– having regard to Rule 115(2) and (3) of its Rules of Procedure,
– having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,
A. whereas on 27 June 2022, Corteva Agriscience Belgium B.V., based in Belgium, on behalf of Corteva Agriscience LLC, based in the United States, submitted an application to the national competent authority of the Netherlands for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize DP910521 (the ‘GM maize’);
B. whereas the GM maize produces the Cry1B.34 toxin and is resistant to the herbicide glufosinate;
C. whereas glufosinate is classified as toxic to reproduction 1B and therefore meets the ‘cut-off criteria’ set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council[5]; whereas the approval of glufosinate for use in the Union expired on 31 July 2018;
D. whereas Cry1B.34 is a synthetic fusion protein combining Cry1B, Cry1Ca1 and Cry9Db1, engineered for insect resistance against lepidopteran pests, without demonstrated specificity to target species;
E. whereas the genetic modification includes a two-step process using CRISPR/Cas9 to insert a ‘landing pad’, followed by microprojectile bombardment for gene expression cassette insertion;
Lack of assessment of the complementary herbicide
F. whereas Commission Implementing Regulation (EU) No 503/2013[6] requires an assessment of whether the expected agricultural practices influence the outcome of the studied endpoints; whereas, according to that Implementing Regulation, this is especially relevant for herbicide-tolerant plants;
G. whereas the vast majority of GM crops have been genetically modified so that they are tolerant to one or more ‘complementary’ herbicides which can be used throughout the cultivation of the GM crop, without the crop dying, as would be the case for a non-herbicide tolerant crop; whereas a number of studies show that herbicide-tolerant GM crops result in a higher use of complementary herbicides, in large part because of the emergence of herbicide-tolerant weeds[7];
H. whereas herbicide-tolerant GM crops lock farmers into a weed management system that is largely or wholly dependent on herbicides, and does so by charging a premium for GM seeds that can be justified only if farmers purchasing such seeds also spray the complementary herbicides; whereas heightened reliance on complementary herbicides on farms planting the GM crops accelerates the emergence and spread of weeds resistant to those herbicides, thereby triggering the need for even more herbicide use, a vicious circle known as ‘the herbicide treadmill’;
I. whereas the adverse impacts stemming from excessive reliance on herbicides will worsen as regards soil health, water quality, and above and below ground biodiversity, and lead to increased human and animal exposure, potentially also via increased herbicide residues on food and feed;
J. whereas assessment of herbicide residues and metabolites found on GM plants is considered outside the remit of the EFSA Panel on Genetically Modified Organisms (‘EFSA GMO Panel’) and is therefore not undertaken as part of the authorisation process for GMOs;
Outstanding questions concerning Bt toxins
K. whereas a number of studies show that side effects have been observed that may affect the immune system following exposure to Bt toxins and that some Bt toxins may have adjuvant properties[8], meaning that they can increase the allergenicity of other proteins with which they come into contact;
L. whereas a scientific study found that the toxicity of Bt toxins may also be increased through interaction with residues from spraying with herbicides, and that further studies are needed on the combinatorial effects of ‘stacked’ events (GM crops which have been modified to be herbicide-tolerant and to produce insecticides in the form of Bt toxins)[9]; whereas assessment of the potential interaction of herbicide residues and their metabolites with Bt toxins is, however, considered to be outside the remit of the EFSA GMO Panel and is, therefore, not undertaken as part of the risk assessment;
Bt crops: effects on non-target organisms
M. whereas, unlike the use of insecticides, where exposure is at the time of spraying and for a limited period afterwards, the use of Bt GM crops leads to continuous exposure of the target and non-target organisms to Bt toxins;
N. whereas the assumption that Bt toxins exhibit a single target-specific mode of action can no longer be considered correct and effects on non-target organisms cannot be excluded; whereas an increasing number of non-target organisms are reported to be affected in many ways;
Member State and stakeholder comments
O. whereas Member States submitted many critical comments to EFSA during the three-month consultation period[10], including that the list of relevant studies, identified in the literature review of the applicant, did not include studies on the fate of Bt proteins in the environment or on potential effects of Btcrop residues on non-target organisms even though such studies exist;
P. whereas field trials conducted for compositional and phenotypic analysis of the GM maize failed to consider diverse environmental conditions and genetic backgrounds relevant to its cultivation, particularly in countries like Brazil;
Q. whereas the toxicity assessment of Cry1B.34 does not account for combinatorial effects with plant constituents or residues from herbicide applications;
R. whereas glufosinate, the complementary herbicide, is associated with significant risks to biodiversity, soil and water quality, and long-term ecosystem health;
S. whereas the risk of gene flow to wild relatives such as teosinte, reported in Spain and France, raises concerns about transgene persistence and environmental impacts;
T. whereas the monitoring requirements under Implementing Regulation (EU) No 503/2013 are inadequately addressed, with no independent verification of data provided;
Ensuring a global level playing field and upholding the Union’s international obligations
U. whereas the conclusions of the Strategic Dialogue on the Future of EU Agriculture[11] call on the Commission to reassess its approach on market access for agri-food imports and exports, given the challenge of diverging standards of the Union and its trading partners; whereas fairer trade relations, on a global level, coherent with goals for a healthy environment, were one of the main demands of farmers during the demonstrations of 2023 and 2024;
V. whereas a 2017 report by the United Nations’ (UN) Special Rapporteur on the right to food found that, particularly in developing countries, hazardous pesticides have catastrophic impacts on health[12]; whereas the UN Sustainable Development Goal (‘UN SDG’) Target 3.9 aims by 2030 to substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination[13];
W. whereas the Kunming-Montreal Global Biodiversity Framework, agreed at the COP15 of the UN Convention on Biological Diversity (‘UN CBD’) in December 2022, includes a global target to reduce the risk of pesticides by at least 50 % by 2030[14];
X. whereas Regulation (EC) No 1829/2003 states that GM food or feed must not have adverse effects on human health, animal health or the environment, and requires the Commission to take into account any relevant provisions of Union law and other legitimate factors relevant to the matter under consideration when drafting its decision; whereas such legitimate factors should include the Union’s obligations under the UN SDGs and the UN CBD;
Reducing dependency on imported feed
Y. whereas one of the lessons from the COVID-19 crisis and the still ongoing war in Ukraine is the need for the Union to end the dependencies on some critical materials; whereas in the mission letter to Commissioner Christophe Hansen, Commission President Ursula von der Leyen asks him to look at ways to reduce imports of critical commodities[15];
Undemocratic decision-making
Z. whereas, in its eighth term, Parliament adopted a total of 36 resolutions objecting to the placing on the market of GMOs for food and feed (33 resolutions) and to the cultivation of GMOs in the Union (three resolutions); whereas, in its ninth term, Parliament adopted 38 resolutions objecting to placing GMOs on the market and has adopted another 8 resolutions objecting to placing GMOs on the market already in the current 10th term ;
AA. whereas despite its own acknowledgement of the democratic shortcomings, the lack of support from Member States and the objections of Parliament, the Commission continues to authorise GMOs;
AB. whereas no change of law is required for the Commission to be able not to authorise GMOs when there is no qualified majority of Member States in favour in the Appeal Committee[16];
AC. whereas the vote on 22 November 2024 of the Standing Committee on Plants, Animals, Food and Feed referred to in Article 35 of Regulation (EC) No 1829/2003 delivered no opinion, meaning that the authorisation was not supported by a qualified majority of Member States; whereas the vote on 17 December 2024 of the Appeal Committee again delivered no opinion;
1. Considers that the draft Commission implementing decision exceeds the implementing powers provided for in Regulation (EC) No 1829/2003;
2. Considers that the draft Commission implementing decision is not consistent with Union law, in that it is not compatible with the aim of Regulation (EC) No 1829/2003, which is, in accordance with the general principles laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council[17], to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, and environmental and consumer interests, in relation to GM food and feed, while ensuring the effective functioning of the internal market;
3. Calls on the Commission to withdraw its draft implementing decision and to submit a new draft to the committee;
4. Calls on the Commission to ensure convergence of standards between the Union and its partners in free trade agreement negotiations, in order to meet Union safety standards;
5. Calls on the Commission not to authorise the GM maize due to the increased risks to biodiversity, food safety and workers’ health in line with the One Health approach;
6. Expects the Commission, as matter of urgency, to deliver on its commitment[18] to come forward with a proposal to ensure that hazardous chemicals banned in the Union are not produced for export;
7. Welcomes the fact that the Commission finally recognised, in a letter of 11 September 2020 to Members, the need to take sustainability into account when it comes to authorisation decisions on GMOs[19]; expresses its deep disappointment, however, that, since then the Commission has continued to authorise GMOs for import into the Union, despite ongoing objections by Parliament and a majority of Member States voting against;
8. Urges the Commission, again, to take into account the Union’s obligations under international agreements, such as the Paris Climate Agreement, the UN CBD and the UN SDGs; reiterates its call for draft implementing acts to be accompanied by an explanatory memorandum explaining how they uphold the principle of ‘do no harm’[20];
9. Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.